FDA product code KNW: Instrument, Biopsy
KNW is the FDA product code for instrument, biopsy. It is a Class II device, regulated under 21 CFR 876.1075 and reviewed by the General and Plastic Surgery panel. FDA has cleared 365 510(k) submissions under KNW, 39 in the last five years, from 178 different applicants. The average 510(k) review took 98 days (median 77); 132 days on average over the last three years. FDA has posted 107 recalls for KNW devices, 17 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Biopsy |
| Device class | Class II |
| Regulation | 21 CFR 876.1075 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KNW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 8 | 104 |
| 2018 | 7 | 134 |
| 2019 | 5 | 93 |
| 2020 | 8 | 113 |
| 2021 | 9 | 108 |
| 2022 | 8 | 209 |
| 2023 | 7 | 152 |
| 2024 | 5 | 130 |
| 2025 | 12 | 179 |
| 2026 | 7 | 88 |
Compare with all 510(k) review times · Search every KNW clearance
Top KNW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Device Technologies, Inc. | 15 | 2010-08-27 |
| C.R. Bard, Inc. | 11 | 2011-06-16 |
| Manan Medical Products, Inc. | 10 | 2005-11-01 |
| Gallini U.S., LLC | 10 | 1999-08-12 |
| Senorx, Inc. | 9 | 2023-10-27 |
173 more applicants have KNW clearances. See the full list in Caduvo.
Most recent KNW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260517 | Zhejiang Curaway Medical Technology Co., Ltd. | Automatic Core Biopsy Instrument | 2026-08-28 | 192 |
| K262571 | Bard Peripheral Vascular, Inc. | EnCor EnCompass Breast Biopsy and Tissue Removal System | 2026-08-14 | 21 |
| K262792 | Hologic, Inc. | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | 2026-08-12 | 6 |
| K260572 | Medimetrix, LLC | Marrow Marxman | 2026-08-04 | 166 |
| K261196 | Promisemed Hangzhou Meditech Co., Ltd. | Promisemed VeriEcto Automatic Biopsy Needles | 2026-05-12 | 29 |
Recalls for KNW devices
107 product recalls in 61 recall events; 17 initiated in the last five years and 20 still open. Most recent: 2026-08-20.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2019 | 14 |
| 2020 | 5 |
| 2021 | 10 |
| 2022 | 3 |
| 2023 | 5 |
| 2024 | 2 |
| 2025 | 2 |
| 2026 | 4 |
Frequently asked questions
What is FDA product code KNW?
KNW is the FDA product code for instrument, biopsy. It is a Class II device, regulated under 21 CFR 876.1075 and reviewed by the General and Plastic Surgery panel.
What device class is KNW?
Class II, regulation 21 CFR 876.1075. Typical premarket route: 510(k).
How long does a 510(k) take for product code KNW?
Across 365 cleared submissions the average was 98 days from receipt to decision (median 77).
Which companies have the most KNW clearances?
Medical Device Technologies, Inc. (15); C.R. Bard, Inc. (11); Manan Medical Products, Inc. (10); Gallini U.S., LLC (10); Senorx, Inc. (9).
Have KNW devices been recalled?
Yes: 107 product recalls across 61 recall events; the most recent began 2026-08-20.
Next steps
- Run an FDA pathway report with predicate devices for product code KNW
- Run a recall and safety report across every KNW manufacturer
- Watch product code KNW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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