{ "code": "JKA", "deviceName": "Tubes, Vials, Systems, Serum Separators, Blood Collection", "deviceClass": "II", "regulationNumber": "862.1675", "panel": "Clinical Chemistry", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 236, "last12Months": 6 }, "adverseEvents": { "total": 14964, "last12Months": 4071 }, "reviewDays": { "median": 91, "sampleSize": 236 }, "recalls": { "total": 170, "recent": [ { "resNumber": "Z-1100-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "ICU Medical, Inc.", "firmAsPublished": "ICU Medical Inc.", "reason": "Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.", "initiated": "2025-12-19" }, { "resNumber": "Z-0544-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "ASP Global, LLC. dba Anatomy Supply Partners, LLC.", "firmAsPublished": "ASP Global, LLC. dba Anatomy Supply Partners, LLC.", "reason": "Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.", "initiated": "2025-09-26" }, { "resNumber": "Z-0545-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "ASP Global, LLC. dba Anatomy Supply Partners, LLC.", "firmAsPublished": "ASP Global, LLC. dba Anatomy Supply Partners, LLC.", "reason": "Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.", "initiated": "2025-09-26" }, { "resNumber": "Z-0546-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "ASP Global, LLC. dba Anatomy Supply Partners, LLC.", "firmAsPublished": "ASP Global, LLC. dba Anatomy Supply Partners, LLC.", "reason": "Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.", "initiated": "2025-09-26" }, { "resNumber": "Z-0547-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "ASP Global, LLC. dba Anatomy Supply Partners, LLC.", "firmAsPublished": "ASP Global, LLC. dba Anatomy Supply Partners, LLC.", "reason": "Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.", "initiated": "2025-09-26" } ] }, "recentClearances": [ { "kNumber": "K252899", "deviceName": "Female Culture Device; Male Culture Device; Transfer Device; Access Device", "applicant": "Zhejiang Kindly Medical Device Co., Ltd.", "company": "Zhejiang Kindly Medical Device Co., Ltd.", "decisionDate": "2026-06-02", "dateReceived": "2025-09-11" }, { "kNumber": "K260128", "deviceName": "BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes", "applicant": "Becton, Dickinson and Company", "company": "Becton, Dickinson and Company", "decisionDate": "2026-04-15", "dateReceived": "2026-01-16" }, { "kNumber": "K252506", "deviceName": "BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder", "applicant": "Becton, Dickinson and Company", "company": "Becton, Dickinson and Company", "decisionDate": "2026-04-10", "dateReceived": "2025-08-08" }, { "kNumber": "K252378", "deviceName": "BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube", "applicant": "Becton, Dickinson and Company", "company": "Becton, Dickinson and Company", "decisionDate": "2026-04-10", "dateReceived": "2025-07-30" }, { "kNumber": "K252040", "deviceName": "BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes", "applicant": "Becton, Dickinson and Company", "company": "Becton, Dickinson and Company", "decisionDate": "2026-03-13", "dateReceived": "2025-06-30" }, { "kNumber": "K251812", "deviceName": "Steripath® Flow™ Blood Collection System", "applicant": "Magnolia Medical Technologies", "company": "Magnolia Medical Technologies, Inc.", "decisionDate": "2025-09-25", "dateReceived": "2025-06-12" }, { "kNumber": "K243207", "deviceName": "BD Vacutainer® Eclipse™ Blood Collection Needle", "applicant": "Becton, Dickinson and Company", "company": "Becton, Dickinson and Company", "decisionDate": "2025-07-03", "dateReceived": "2024-10-01" }, { "kNumber": "K250961", "deviceName": "Blood collection tube holders", "applicant": "Promisemed Hangzhou Meditech Co., Ltd.", "company": "Promisemed Hangzhou Meditech Co., Ltd.", "decisionDate": "2025-06-04", "dateReceived": "2025-03-31" }, { "kNumber": "K244047", "deviceName": "Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)", "applicant": "Venocare, Inc.", "company": "Venocare, Inc.", "decisionDate": "2025-05-23", "dateReceived": "2024-12-31" }, { "kNumber": "K250907", "deviceName": "Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set", "applicant": "Sol-Millennium Medical, Inc.", "company": "Sol-Millennium Medical, Inc.", "decisionDate": "2025-04-30", "dateReceived": "2025-03-26" } ], "topApplicants": [ { "name": "Becton, Dickinson and Company", "count": 18 }, { "name": "Bd Becton Dickinson Vacutainer Systems Preanalytic", "count": 13 }, { "name": "Becton Dickinson Vacutainer Systems", "count": 11 }, { "name": "Sherwood Medical Co.", "count": 9 }, { "name": "Becton, Dickinson & CO", "count": 8 } ], "topCompanies": [ { "name": "Becton, Dickinson and Company", "count": 26, "spellings": 2 }, { "name": "Bd Becton Dickinson Vacutainer Systems Preanalytic", "count": 13, "spellings": 1 }, { "name": "Becton Dickinson Vacutainer Systems", "count": 11, "spellings": 1 }, { "name": "Sherwood Medical Co.", "count": 9, "spellings": 1 }, { "name": "Greiner America, Inc.", "count": 6, "spellings": 1 } ], "newEntrants": [ { "name": "Zhejiang Kindly Medical Device Co., Ltd.", "since": "2026-06-02", "kNumber": "K252899" } ], "baseline": { "months": [ { "month": "2023-01-01", "observed": 346, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 255, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 302, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 361, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 359, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 440, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 337, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 418, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 217, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 381, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 322, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 536, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 410, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 405, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 355, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 336, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 374, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 365, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 299, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 393, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 434, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 303, "expectedLow": 207.9129324812804, "expectedHigh": 493.4077658200275, "isSufficient": true }, { "month": "2025-02-01", "observed": 367, "expectedLow": 164.25551797440286, "expectedHigh": 420.4451555775453, "isSufficient": true }, { "month": "2025-03-01", "observed": 466, "expectedLow": 210.45217316986557, "expectedHigh": 500.02092176731566, "isSufficient": true }, { "month": "2025-04-01", "observed": 480, "expectedLow": 275.70180714421895, "expectedHigh": 523.8101552991932, "isSufficient": true }, { "month": "2025-05-01", "observed": 485, "expectedLow": 268.0084383941108, "expectedHigh": 525.9672527759075, "isSufficient": true }, { "month": "2025-06-01", "observed": 415, "expectedLow": 281.54316518367625, "expectedHigh": 596.1570506099354, "isSufficient": true }, { "month": "2025-07-01", "observed": 513, "expectedLow": 426.5824701736236, "expectedHigh": 927.6113871295238, "isSufficient": true }, { "month": "2025-08-01", "observed": 392, "expectedLow": 292.9165036388182, "expectedHigh": 657.3098195839558, "isSufficient": true }, { "month": "2025-09-01", "observed": 789, "expectedLow": 282.87036444915844, "expectedHigh": 664.824983782954, "isSufficient": true }, { "month": "2025-10-01", "observed": 597, "expectedLow": 305.4713445441178, "expectedHigh": 821.1651494157477, "isSufficient": true }, { "month": "2025-11-01", "observed": 505, "expectedLow": 307.7233645516094, "expectedHigh": 729.0377940428165, "isSufficient": true }, { "month": "2025-12-01", "observed": 690, "expectedLow": 342.1627711336769, "expectedHigh": 798.6532526588453, "isSufficient": true }, { "month": "2026-01-01", "observed": 473, "expectedLow": 419.68637994597697, "expectedHigh": 976.0933137676834, "isSufficient": true }, { "month": "2026-02-01", "observed": 357, "expectedLow": 310.23431343802724, "expectedHigh": 760.2299422444643, "isSufficient": true }, { "month": "2026-03-01", "observed": 376, "expectedLow": 256.6433589974183, "expectedHigh": 801.7163683457198, "isSufficient": true } ], "sufficientMonths": 15, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1100-2026, Z-0544-2026, Z-0545-2026, Z-0546-2026, Z-0547-2026). 1 first-time filer in the last 12 months, Zhejiang Kindly Medical Device Co., Ltd (K252899). The code is crowded, scoring 75 of 100 — 113 companies hold a clearance here and 6 arrived in the last 12 months (JKA:crowding).", "severity": 75, "factors": [ { "kind": "recall", "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)", "recordIds": [ "Z-1100-2026", "Z-0544-2026", "Z-0545-2026", "Z-0546-2026", "Z-0547-2026" ], "severity": 75 }, { "kind": "new_entrant", "detail": "1 first-time filer in the last 12 months, Zhejiang Kindly Medical Device Co., Ltd.", "recordIds": [ "K252899" ], "severity": 41 }, { "kind": "crowding", "detail": "the code is crowded, scoring 75 of 100 — 113 companies hold a clearance here and 6 arrived in the last 12 months", "recordIds": [ "JKA: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%3AJKA" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJKA" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJKA" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJKA" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJKA" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJKA" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJKA" } ], "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": "2026-08-11T13:51:45.722Z" }