{
  "code": "LJS",
  "deviceName": "Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days",
  "deviceClass": "II",
  "regulationNumber": "880.5970",
  "panel": "General Hospital",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 302,
    "last12Months": 3
  },
  "adverseEvents": {
    "total": 11493,
    "last12Months": 2431
  },
  "reviewDays": {
    "median": 90,
    "sampleSize": 302
  },
  "recalls": {
    "total": 332,
    "recent": [
      {
        "resNumber": "Z-2803-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Argon Medical Devices, Inc",
        "firmAsPublished": "Argon Medical Devices, Inc",
        "reason": "Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.",
        "initiated": "2026-06-15"
      },
      {
        "resNumber": "Z-2804-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Argon Medical Devices, Inc",
        "firmAsPublished": "Argon Medical Devices, Inc",
        "reason": "Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.",
        "initiated": "2026-06-15"
      },
      {
        "resNumber": "Z-2658-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Bard Access Systems, Inc.",
        "firmAsPublished": "Bard Access Systems, Inc.",
        "reason": "Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.",
        "initiated": "2026-05-21"
      },
      {
        "resNumber": "Z-2659-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Bard Access Systems, Inc.",
        "firmAsPublished": "Bard Access Systems, Inc.",
        "reason": "Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.",
        "initiated": "2026-05-21"
      },
      {
        "resNumber": "Z-2664-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Bard Access Systems, Inc.",
        "firmAsPublished": "Bard Access Systems, Inc.",
        "reason": "Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.",
        "initiated": "2026-05-21"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K260929",
      "deviceName": "Neonav ECG Tip Location System",
      "applicant": "Navi Medical Technologies",
      "company": "NAVI MEDICAL TECHNOLOGIES PTY LTD",
      "decisionDate": "2026-04-17",
      "dateReceived": "2026-03-20"
    },
    {
      "kNumber": "K252373",
      "deviceName": "BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology",
      "applicant": "Spectrum Vascular",
      "company": "Spectrum Vascular",
      "decisionDate": "2025-12-16",
      "dateReceived": "2025-07-30"
    },
    {
      "kNumber": "K252792",
      "deviceName": "PM2™ System with ECGuide™ Connector",
      "applicant": "Piccolo Medical, Inc.",
      "company": "Piccolo Medical, Inc.",
      "decisionDate": "2025-11-17",
      "dateReceived": "2025-09-02"
    },
    {
      "kNumber": "K243458",
      "deviceName": "HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr",
      "applicant": "Access Vascular, Inc.",
      "company": "Access Vascular, Inc.",
      "decisionDate": "2025-08-01",
      "dateReceived": "2024-11-08"
    },
    {
      "kNumber": "K251212",
      "deviceName": "Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM)  (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)",
      "applicant": "Access Vascular, Inc.",
      "company": "Access Vascular, Inc.",
      "decisionDate": "2025-07-01",
      "dateReceived": "2025-04-18"
    },
    {
      "kNumber": "K243484",
      "deviceName": "PM2+ System and SmartPICC Stylet",
      "applicant": "Piccolo Medical, Inc.",
      "company": "Piccolo Medical, Inc.",
      "decisionDate": "2025-05-29",
      "dateReceived": "2024-11-08"
    },
    {
      "kNumber": "K241587",
      "deviceName": "pilot TLS",
      "applicant": "Vygon Corporation",
      "company": "Vygon Corporation",
      "decisionDate": "2025-02-26",
      "dateReceived": "2024-06-03"
    },
    {
      "kNumber": "K241910",
      "deviceName": "Neonav ECG Tip Location System",
      "applicant": "Navi Medical Technologies",
      "company": "NAVI MEDICAL TECHNOLOGIES PTY LTD",
      "decisionDate": "2025-01-19",
      "dateReceived": "2024-07-01"
    },
    {
      "kNumber": "K243941",
      "deviceName": "HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire  - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire  - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204)",
      "applicant": "Access Vascular, Inc.",
      "company": "Access Vascular, Inc.",
      "decisionDate": "2025-01-17",
      "dateReceived": "2024-12-20"
    },
    {
      "kNumber": "K240486",
      "deviceName": "PM2 System and ECGuide Connector",
      "applicant": "Piccolo Medical, Inc.",
      "company": "Piccolo Medical, Inc.",
      "decisionDate": "2024-09-08",
      "dateReceived": "2024-02-20"
    }
  ],
  "topApplicants": [
    {
      "name": "C.R. Bard, Inc.",
      "count": 34
    },
    {
      "name": "Navilyst Medical, Inc.",
      "count": 16
    },
    {
      "name": "Medcomp",
      "count": 11
    },
    {
      "name": "AngioDynamics, Inc.",
      "count": 10
    },
    {
      "name": "Vygon Corp.",
      "count": 10
    }
  ],
  "topCompanies": [
    {
      "name": "C.R. Bard, Inc.",
      "count": 34,
      "spellings": 1
    },
    {
      "name": "Navilyst Medical, Inc.",
      "count": 16,
      "spellings": 1
    },
    {
      "name": "Arrow International, Inc., Division of Teleflex Medical Inc.",
      "count": 15,
      "spellings": 6
    },
    {
      "name": "Medcomp (Dba Medical Components, Inc.)",
      "count": 11,
      "spellings": 1
    },
    {
      "name": "Medical Components, Inc dba MedComp",
      "count": 11,
      "spellings": 3
    }
  ],
  "newEntrants": [
    {
      "name": "Spectrum Vascular",
      "since": "2025-12-16",
      "kNumber": "K252373"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 158,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 143,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 236,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 238,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 215,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 282,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 247,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 282,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 223,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 234,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 267,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 289,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 267,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 325,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 360,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 385,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 391,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 329,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 452,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 425,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 519,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 402,
        "expectedLow": 254.46517667268338,
        "expectedHigh": 522.2586013461741,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 403,
        "expectedLow": 236.34409605498192,
        "expectedHigh": 448.18418118516047,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 326,
        "expectedLow": 280.31150677548817,
        "expectedHigh": 527.2322491111912,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 377,
        "expectedLow": 271.54791801815,
        "expectedHigh": 514.2840362019211,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 349,
        "expectedLow": 265.0920497935235,
        "expectedHigh": 463.80016343641717,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 312,
        "expectedLow": 280.22579962264837,
        "expectedHigh": 467.8277608300517,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 435,
        "expectedLow": 400.6931608211166,
        "expectedHigh": 715.2371883205899,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 353,
        "expectedLow": 261.55383017400754,
        "expectedHigh": 526.3542935004733,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 325,
        "expectedLow": 254.40411807344086,
        "expectedHigh": 547.4575249392632,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 303,
        "expectedLow": 220.1083835213823,
        "expectedHigh": 534.0876471852474,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 323,
        "expectedLow": 162.68960124165812,
        "expectedHigh": 477.04432428498217,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 336,
        "expectedLow": 181.42982529075292,
        "expectedHigh": 531.9580847149379,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 289,
        "expectedLow": 225.42121088623534,
        "expectedHigh": 580.9632883514784,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 337,
        "expectedLow": 152.7110675512394,
        "expectedHigh": 473.4620703543327,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 238,
        "expectedLow": 223.6314470190241,
        "expectedHigh": 473.9600326061214,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2803-2026, Z-2804-2026, Z-2658-2026, Z-2659-2026, Z-2664-2026). 1 first-time filer in the last 12 months, Spectrum Vascular (K252373). The code is crowded, scoring 69 of 100 — 97 companies hold a clearance here and 3 arrived in the last 12 months (LJS:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2803-2026",
          "Z-2804-2026",
          "Z-2658-2026",
          "Z-2659-2026",
          "Z-2664-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Spectrum Vascular",
        "recordIds": [
          "K252373"
        ],
        "severity": 41
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 69 of 100 — 97 companies hold a clearance here and 3 arrived in the last 12 months",
        "recordIds": [
          "LJS:crowding"
        ],
        "severity": 20
      }
    ],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3ALJS"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALJS"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALJS"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ALJS"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ALJS"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ALJS"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ALJS"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.738Z"
}