FDA product code · Gastroenterology, Urology
KNWInstrument, Biopsy
Product code KNW covers Instrument, Biopsy, a Class II device regulated under 21 CFR 876.1075. FDA has cleared 361 devices in this code, 5 of them in the last 12 months. Median review time across the 361 most recent decisions is 77 days. openFDA lists 106 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 876.1075
- Review panel
- Gastroenterology, Urology
- Clearances
- 361
What is happening in KNW right now?
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).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class I recall | Z-2706-2026, Z-2707-2026, Z-2709-2026, Z-1314-2026 |
| New entrant | Worth knowing | K252183 |
| Crowding | Context | KNW:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in KNW?
FDA has cleared 361 devices under product code KNW since the 510(k) programme began in 1976, 5 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261196 | Promisemed VeriEcto Automatic Biopsy Needles | Promisemed Hangzhou Meditech Co., Ltd. | |
| K260365 | 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 | Devicor Medical Products, Inc. | |
| K252795 | 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 | Argon Medical Devices, Inc. | |
| K252681 | EnCor EnCompass Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | |
| K252183 | Resitu Slider 09 (RESL09) | Resitu Medical AB | |
| K243407 | Forcyte Autograft Harvest Kit | Forcyte Medical, LLC | |
| K244018 | Disposable Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | |
| K243296 | Disposable Biopsy Needle | Carbon (Shenzhen) Medical Device Co., Ltd. | |
| K250032 | Marquee Disposable Core Biopsy Instrument and Instrument Kit | Bard Peripheral Vascular, Inc. | |
| K243886 | ExpressCore Biopsy Device | Inrad, Inc. |
How long does FDA review take for KNW?
The median FDA review time for KNW is 77 days, measured across the 361 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in KNW?
openFDA lists 106 recall records against product code KNW. A recall record covers one firm's corrective action and may span many device lots.
Z-2706-2026Open, ClassifiedArgon Medical Devices, Inc
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Z-2707-2026Open, ClassifiedArgon Medical Devices, Inc
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Z-2709-2026Open, ClassifiedArgon Medical Devices, Inc
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Z-1314-2026Open, ClassifiedHologic, Inc.
Presence of particulates in affected devices that can be deposited into breast tissue during use.
Z-1170-2025Open, ClassifiedHologic, Inc.
Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
Showing the 5 most recently initiated of 106. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for KNW?
MAUDE holds 4,330 adverse-event reports naming product code KNW, 1,629 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in KNW unusual?
3 months sit above KNW's own expected range: 1 December 2025, 1 January 2026, 1 February 2026.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 31 | Insufficient history | No expected range — too little history | |
| 74 | Insufficient history | No expected range — too little history | |
| 68 | Insufficient history | No expected range — too little history | |
| 57 | Insufficient history | No expected range — too little history | |
| 58 | Insufficient history | No expected range — too little history | |
| 75 | Insufficient history | No expected range — too little history | |
| 47 | Insufficient history | No expected range — too little history | |
| 51 | Insufficient history | No expected range — too little history | |
| 63 | Insufficient history | No expected range — too little history | |
| 159 | Insufficient history | No expected range — too little history | |
| 101 | Insufficient history | No expected range — too little history | |
| 59 | Insufficient history | No expected range — too little history | |
| 104 | Insufficient history | No expected range — too little history | |
| 76 | Insufficient history | No expected range — too little history | |
| 156 | Insufficient history | No expected range — too little history | |
| 89 | Insufficient history | No expected range — too little history | |
| 128 | Insufficient history | No expected range — too little history | |
| 157 | Insufficient history | No expected range — too little history | |
| 71 | Insufficient history | No expected range — too little history | |
| 66 | Insufficient history | No expected range — too little history | |
| 117 | Insufficient history | No expected range — too little history | |
| 72 | 20–169 | Within expected (20–169) | |
| 125 | 16–135 | Within expected (16–135) | |
| 109 | 28–173 | Within expected (28–173) | |
| 140 | 37–178 | Within expected (37–178) | |
| 128 | 40–179 | Within expected (40–179) | |
| 97 | 50–191 | Within expected (50–191) | |
| 154 | 79–274 | Within expected (79–274) | |
| 187 | 58–200 | Within expected (58–200) | |
| 159 | 71–238 | Within expected (71–238) | |
| 155 | 73–234 | Within expected (73–234) | |
| 126 | 74–204 | Within expected (74–204) | |
| 209 | 91–209 | Above expected (91–209) | |
| 297 | 115–271 | Above expected (115–271) | |
| 316 | 114–268 | Above expected (114–268) | |
| 227 | 121–378 | Within expected (121–378) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in KNW.
Who has entered KNW in the last year?
One company filed in KNW for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Resitu Medical AB | K252183 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in KNW?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in KNW?
Across the 361 most recent decisions, these applicants filed most often in KNW.
| Applicant | Recent clearances |
|---|---|
| Medical Device Technologies, Inc. | 15 |
| C.R. Bard, Inc. | 11 |
| Gallini U.S., LLC | 10 |
| Manan Medical Products, Inc. | 10 |
| Senorx, Inc. | 9 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in KNW files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Daum Corp. | 9 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch KNW
Get an email the morning anything changes in KNW — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.