{ "code": "KNW", "deviceName": "Instrument, Biopsy", "deviceClass": "II", "regulationNumber": "876.1075", "panel": "Gastroenterology, Urology", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 361, "last12Months": 5 }, "adverseEvents": { "total": 4330, "last12Months": 1629 }, "reviewDays": { "median": 77, "sampleSize": 361 }, "recalls": { "total": 106, "recent": [ { "resNumber": "Z-2706-2026", "status": "Open, Classified", "recallClass": "Class I", "firm": "Argon Medical Devices, Inc", "firmAsPublished": "Argon Medical Devices, Inc", "reason": "Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.", "initiated": "2026-06-01" }, { "resNumber": "Z-2707-2026", "status": "Open, Classified", "recallClass": "Class I", "firm": "Argon Medical Devices, Inc", "firmAsPublished": "Argon Medical Devices, Inc", "reason": "Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.", "initiated": "2026-06-01" }, { "resNumber": "Z-2709-2026", "status": "Open, Classified", "recallClass": "Class I", "firm": "Argon Medical Devices, Inc", "firmAsPublished": "Argon Medical Devices, Inc", "reason": "Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.", "initiated": "2026-06-01" }, { "resNumber": "Z-1314-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Hologic, Inc.", "firmAsPublished": "Hologic, Inc", "reason": "Presence of particulates in affected devices that can be deposited into breast tissue during use.", "initiated": "2025-12-15" }, { "resNumber": "Z-1170-2025", "status": "Open, Classified", "recallClass": "Class II", "firm": "Hologic, Inc.", "firmAsPublished": "Hologic, Inc", "reason": "Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.", "initiated": "2025-01-15" } ] }, "recentClearances": [ { "kNumber": "K261196", "deviceName": "Promisemed VeriEcto Automatic Biopsy Needles", "applicant": "Promisemed Hangzhou Meditech Co., Ltd.", "company": "Promisemed Hangzhou Meditech Co., Ltd.", "decisionDate": "2026-05-12", "dateReceived": "2026-04-13" }, { "kNumber": "K260365", "deviceName": "Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery Char", "applicant": "Devicor Medical Products, Inc.", "company": "Devicor Medical Products Inc", "decisionDate": "2026-03-04", "dateReceived": "2026-02-04" }, { "kNumber": "K252795", "deviceName": "ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial", "applicant": "Argon Medical Devices, Inc.", "company": "Argon Medical Devices, Inc", "decisionDate": "2026-02-23", "dateReceived": "2025-09-02" }, { "kNumber": "K252681", "deviceName": "EnCor EnCompass™ Breast Biopsy and Tissue Removal System", "applicant": "Bard Peripheral Vascular, Inc.", "company": "BARD PERIPHERAL VASCULAR, INC", "decisionDate": "2025-12-12", "dateReceived": "2025-08-25" }, { "kNumber": "K252183", "deviceName": "Resitu Slider 09 (RESL09)", "applicant": "Resitu Medical AB", "company": "Resitu Medical AB", "decisionDate": "2025-09-24", "dateReceived": "2025-07-11" }, { "kNumber": "K243407", "deviceName": "Forcyte Autograft Harvest Kit", "applicant": "Forcyte Medical, LLC", "company": "Forcyte Medical, LLC", "decisionDate": "2025-07-29", "dateReceived": "2024-11-01" }, { "kNumber": "K244018", "deviceName": "Disposable Biopsy Needle", "applicant": "Zhejiang Curaway Medical Technology Co., Ltd.", "company": "Zhejiang Curaway Medical Technology Co., Ltd.", "decisionDate": "2025-07-22", "dateReceived": "2024-12-27" }, { "kNumber": "K243296", "deviceName": "Disposable Biopsy Needle", "applicant": "Carbon (Shenzhen) Medical Device Co., Ltd.", "company": "Carbon (Shenzhen) Medical Device Co., Ltd.", "decisionDate": "2025-07-11", "dateReceived": "2024-10-18" }, { "kNumber": "K250032", "deviceName": "Marquee™ Disposable Core Biopsy Instrument and Instrument Kit", "applicant": "Bard Peripheral Vascular, Inc.", "company": "BARD PERIPHERAL VASCULAR, INC", "decisionDate": "2025-07-10", "dateReceived": "2025-01-07" }, { "kNumber": "K243886", "deviceName": "ExpressCore Biopsy Device", "applicant": "Inrad, Inc.", "company": "Inrad, Inc.", "decisionDate": "2025-04-29", "dateReceived": "2024-12-18" } ], "topApplicants": [ { "name": "Medical Device Technologies, Inc.", "count": 15 }, { "name": "C.R. Bard, Inc.", "count": 11 }, { "name": "Gallini U.S., LLC", "count": 10 }, { "name": "Manan Medical Products, Inc.", "count": 10 }, { "name": "Senorx, Inc.", "count": 9 } ], "topCompanies": [ { "name": "Medical Device Technologies, Inc.", "count": 15, "spellings": 1 }, { "name": "C.R. Bard, Inc.", "count": 11, "spellings": 1 }, { "name": "Gallini U.S., LLC", "count": 10, "spellings": 1 }, { "name": "Manan Medical Products, Inc.", "count": 10, "spellings": 1 }, { "name": "Daum Corp.", "count": 9, "spellings": 2 } ], "newEntrants": [ { "name": "Resitu Medical AB", "since": "2025-09-24", "kNumber": "K252183" } ], "baseline": { "months": [ { "month": "2023-01-01", "observed": 31, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 74, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 68, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 57, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 58, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 75, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 47, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 51, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 63, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 159, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 101, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 59, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 104, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 76, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 156, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 89, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 128, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 157, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 71, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 66, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 117, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 72, "expectedLow": 19.707868524464605, "expectedHigh": 168.95748337715358, "isSufficient": true }, { "month": "2025-02-01", "observed": 125, "expectedLow": 15.979126710898836, "expectedHigh": 135.36765940654325, "isSufficient": true }, { "month": "2025-03-01", "observed": 109, "expectedLow": 28.46557629154943, "expectedHigh": 172.93025113573728, "isSufficient": true }, { "month": "2025-04-01", "observed": 140, "expectedLow": 36.5540068963755, "expectedHigh": 178.0382882436696, "isSufficient": true }, { "month": "2025-05-01", "observed": 128, "expectedLow": 40.1367319142677, "expectedHigh": 178.61242551168215, "isSufficient": true }, { "month": "2025-06-01", "observed": 97, "expectedLow": 50.18931069988179, "expectedHigh": 190.6975366334956, "isSufficient": true }, { "month": "2025-07-01", "observed": 154, "expectedLow": 78.81294043890477, "expectedHigh": 274.1540343472694, "isSufficient": true }, { "month": "2025-08-01", "observed": 187, "expectedLow": 57.61191612546764, "expectedHigh": 200.09365000168273, "isSufficient": true }, { "month": "2025-09-01", "observed": 159, "expectedLow": 70.51114394934001, "expectedHigh": 238.48138543568845, "isSufficient": true }, { "month": "2025-10-01", "observed": 155, "expectedLow": 72.85947334982005, "expectedHigh": 233.95149407709152, "isSufficient": true }, { "month": "2025-11-01", "observed": 126, "expectedLow": 73.81308403672757, "expectedHigh": 203.54574984248362, "isSufficient": true }, { "month": "2025-12-01", "observed": 209, "expectedLow": 91.42822817082649, "expectedHigh": 208.96215289321023, "isSufficient": true }, { "month": "2026-01-01", "observed": 297, "expectedLow": 114.89295058625865, "expectedHigh": 271.1455122787913, "isSufficient": true }, { "month": "2026-02-01", "observed": 316, "expectedLow": 114.11610195600032, "expectedHigh": 267.5664231521412, "isSufficient": true }, { "month": "2026-03-01", "observed": 227, "expectedLow": 121.14272708108835, "expectedHigh": 378.4843574837465, "isSufficient": true } ], "sufficientMonths": 15, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "KNW (Instrument, Biopsy) has three findings, most consequential first. 4 recalls opened in the last 12 months and not yet terminated (Class I, Class II) (Z-2706-2026, Z-2707-2026, Z-2709-2026, Z-1314-2026). 1 first-time filer in the last 12 months, Resitu Medical AB (K252183). The code is crowded, scoring 78 of 100 — 167 companies hold a clearance here and 5 arrived in the last 12 months (KNW:crowding).", "severity": 85, "factors": [ { "kind": "recall", "detail": "4 recalls opened in the last 12 months and not yet terminated (Class I, Class II)", "recordIds": [ "Z-2706-2026", "Z-2707-2026", "Z-2709-2026", "Z-1314-2026" ], "severity": 85 }, { "kind": "new_entrant", "detail": "1 first-time filer in the last 12 months, Resitu Medical AB", "recordIds": [ "K252183" ], "severity": 41 }, { "kind": "crowding", "detail": "the code is crowded, scoring 78 of 100 — 167 companies hold a clearance here and 5 arrived in the last 12 months", "recordIds": [ "KNW: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%3AKNW" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKNW" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKNW" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AKNW" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AKNW" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AKNW" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AKNW" } ], "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": "2026-08-11T13:51:45.733Z" }