{ "code": "LJT", "deviceName": "Port & Catheter, Implanted, Subcutaneous, Intravascular", "deviceClass": "II", "regulationNumber": "880.5965", "panel": "General Hospital", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 288, "last12Months": 2 }, "adverseEvents": { "total": 8017, "last12Months": 3166 }, "reviewDays": { "median": 92, "sampleSize": 288 }, "recalls": { "total": 141, "recent": [ { "resNumber": "Z-2395-2026", "status": "Open, Classified", "recallClass": "Class I", "firm": "Arrow International, Inc., Division of Teleflex Medical Inc.", "firmAsPublished": "ARROW INTERNATIONAL, LLC", "reason": "Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.", "initiated": "2026-04-21" }, { "resNumber": "Z-2528-2025", "status": "Open, Classified", "recallClass": "Class II", "firm": "B.Braun Medical S.A.S.", "firmAsPublished": "B.Braun Medical S.A.S.", "reason": "The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.", "initiated": "2025-07-21" }, { "resNumber": "Z-1277-2025", "status": "Open, Classified", "recallClass": "Class I", "firm": "Smiths Medical ASD, Inc.", "firmAsPublished": "Smiths Medical ASD, Inc.", "reason": "The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.", "initiated": "2025-02-13" }, { "resNumber": "Z-1278-2025", "status": "Open, Classified", "recallClass": "Class I", "firm": "Smiths Medical ASD, Inc.", "firmAsPublished": "Smiths Medical ASD, Inc.", "reason": "The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.", "initiated": "2025-02-13" }, { "resNumber": "Z-1279-2025", "status": "Open, Classified", "recallClass": "Class I", "firm": "Smiths Medical ASD, Inc.", "firmAsPublished": "Smiths Medical ASD, Inc.", "reason": "The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.", "initiated": "2025-02-13" } ] }, "recentClearances": [ { "kNumber": "K260916", "deviceName": "FLEXI-PORT™ Power Injectable Implantable Port", "applicant": "Portal Access, Inc.", "company": "Portal Access, Inc.", "decisionDate": "2026-06-17", "dateReceived": "2026-03-19" }, { "kNumber": "K252478", "deviceName": "Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port", "applicant": "Bard Access Systems, Inc.", "company": "Bard Access Systems, Inc.", "decisionDate": "2025-09-05", "dateReceived": "2025-08-07" }, { "kNumber": "K251253", "deviceName": "PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port", "applicant": "Bard Access Systems, Inc.", "company": "Bard Access Systems, Inc.", "decisionDate": "2025-06-18", "dateReceived": "2025-04-23" }, { "kNumber": "K242328", "deviceName": "PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports", "applicant": "Bard Access Systems, Inc.", "company": "Bard Access Systems, Inc.", "decisionDate": "2024-10-31", "dateReceived": "2024-08-06" }, { "kNumber": "K232737", "deviceName": "PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable Port", "applicant": "Bard Peripheral Vascular, Inc.", "company": "BARD PERIPHERAL VASCULAR, INC", "decisionDate": "2023-12-08", "dateReceived": "2023-09-07" }, { "kNumber": "K190559", "deviceName": "SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports", "applicant": "AngioDynamics, Inc.", "company": "Angiodynamics", "decisionDate": "2020-05-22", "dateReceived": "2019-03-05" }, { "kNumber": "K181446", "deviceName": "Bard Power-Injectable Implantable Ports (PowerPorts®)", "applicant": "C.R. Bard, Inc.", "company": "C.R. Bard, Inc.", "decisionDate": "2019-07-08", "dateReceived": "2018-06-01" }, { "kNumber": "K151239", "deviceName": "NMI DUAL PORT II", "applicant": "Navilyst Medical, Inc.", "company": "Navilyst Medical, Inc.", "decisionDate": "2016-06-06", "dateReceived": "2015-05-11" }, { "kNumber": "K153359", "deviceName": "BardPort®, SlimPort®, and X-Port® Implanted Ports", "applicant": "C.R. Bard, Inc.", "company": "C.R. Bard, Inc.", "decisionDate": "2016-05-20", "dateReceived": "2015-11-20" }, { "kNumber": "K153238", "deviceName": "Dignity Dual Port", "applicant": "Medcomp ( Medical Components)", "company": "Medcomp (Medical Components, Inc.)", "decisionDate": "2016-03-15", "dateReceived": "2015-11-09" } ], "topApplicants": [ { "name": "Strato Medical Corp.", "count": 27 }, { "name": "Therex Corp.", "count": 24 }, { "name": "C.R. Bard, Inc.", "count": 22 }, { "name": "Med Institute, Inc.", "count": 17 }, { "name": "Norfolk Medical Products, Inc.", "count": 14 } ], "topCompanies": [ { "name": "Strato Medical Corp.", "count": 27, "spellings": 1 }, { "name": "Therex Corp.", "count": 24, "spellings": 1 }, { "name": "C.R. Bard, Inc.", "count": 22, "spellings": 1 }, { "name": "Med Institute, Inc.", "count": 17, "spellings": 1 }, { "name": "Norfolk Medical Products, Inc.", "count": 14, "spellings": 1 } ], "newEntrants": [ { "name": "Portal Access, Inc.", "since": "2026-06-17", "kNumber": "K260916" } ], "baseline": { "months": [ { "month": "2023-01-01", "observed": 74, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 55, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 75, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 88, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 162, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 97, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 67, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 120, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 91, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 121, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 125, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 118, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 174, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 147, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 123, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 196, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 133, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 204, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 204, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 207, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 144, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 187, "expectedLow": 97.08905426403237, "expectedHigh": 217.32791020744074, "isSufficient": true }, { "month": "2025-02-01", "observed": 246, "expectedLow": 92.16669602679202, "expectedHigh": 197.40285448625266, "isSufficient": true }, { "month": "2025-03-01", "observed": 192, "expectedLow": 106.02278623713073, "expectedHigh": 285.8524136302784, "isSufficient": true }, { "month": "2025-04-01", "observed": 241, "expectedLow": 113.0592481381668, "expectedHigh": 291.1359803975653, "isSufficient": true }, { "month": "2025-05-01", "observed": 305, "expectedLow": 109.13112434773163, "expectedHigh": 290.8008423100257, "isSufficient": true }, { "month": "2025-06-01", "observed": 366, "expectedLow": 119.47637502946208, "expectedHigh": 360.23923160113685, "isSufficient": true }, { "month": "2025-07-01", "observed": 450, "expectedLow": 201.69071429282317, "expectedHigh": 673.4164537432906, "isSufficient": true }, { "month": "2025-08-01", "observed": 373, "expectedLow": 150.35023733571344, "expectedHigh": 514.9259714034174, "isSufficient": true }, { "month": "2025-09-01", "observed": 524, "expectedLow": 180.43036412493552, "expectedHigh": 547.5472636418353, "isSufficient": true }, { "month": "2025-10-01", "observed": 482, "expectedLow": 190.20788829210738, "expectedHigh": 627.9460395440155, "isSufficient": true }, { "month": "2025-11-01", "observed": 430, "expectedLow": 184.08128591808656, "expectedHigh": 593.1534653663451, "isSufficient": true }, { "month": "2025-12-01", "observed": 478, "expectedLow": 215.02159725435334, "expectedHigh": 671.6787808817066, "isSufficient": true }, { "month": "2026-01-01", "observed": 222, "expectedLow": 297.1555018462176, "expectedHigh": 752.1774719281784, "isSufficient": true }, { "month": "2026-02-01", "observed": 311, "expectedLow": 165.39683938244468, "expectedHigh": 571.7717862185791, "isSufficient": true }, { "month": "2026-03-01", "observed": 444, "expectedLow": 158.45511818398958, "expectedHigh": 608.7525767918095, "isSufficient": true } ], "sufficientMonths": 15, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class I) (Z-2395-2026). 1 first-time filer in the last 12 months, Portal Access, Inc (K260916). The code is crowded, scoring 65 of 100 — 79 companies hold a clearance here and 2 arrived in the last 12 months (LJT:crowding).", "severity": 85, "factors": [ { "kind": "recall", "detail": "1 recall opened in the last 12 months and not yet terminated (Class I)", "recordIds": [ "Z-2395-2026" ], "severity": 85 }, { "kind": "new_entrant", "detail": "1 first-time filer in the last 12 months, Portal Access, Inc.", "recordIds": [ "K260916" ], "severity": 41 }, { "kind": "crowding", "detail": "the code is crowded, scoring 65 of 100 — 79 companies hold a clearance here and 2 arrived in the last 12 months", "recordIds": [ "LJT: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%3ALJT" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALJT" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALJT" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3ALJT" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ALJT" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ALJT" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ALJT" } ], "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" }