Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KNW — Predicate Candidate Screening
362 FDA 510(k) clearances under this product code; the 50 most recent screened below.
77 daysmedian FDA review time
215 days90th percentile
362clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260572 | Marrow Marxman | Medimetrix, LLC | 2026-08-04 | 166 | 0 |
| K261196 | Promisemed VeriEcto Automatic Biopsy Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2026-05-12 | 29 | 0 |
| K260365 | Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy Syste | Devicor Medical Products, Inc. | 2026-03-04 | 28 | 0 |
| K252795 | ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore | Argon Medical Devices, Inc. | 2026-02-23 | 174 | 0 |
| K252681 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | 2025-12-12 | 109 | 0 |
| K252183 | Resitu Slider 09 (RESL09) | Resitu Medical AB | 2025-09-24 | 75 | 0 |
| K243407 | Forcyte Autograft Harvest Kit | Forcyte Medical, LLC | 2025-07-29 | 270 | 0 |
| K244018 | Disposable Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-07-22 | 207 | 0 |
| K243296 | Disposable Biopsy Needle | Carbon (Shenzhen) Medical Device Co., Ltd. | 2025-07-11 | 266 | 0 |
| K250032 | Marquee™ Disposable Core Biopsy Instrument and Instrument Ki | Bard Peripheral Vascular, Inc. | 2025-07-10 | 184 | 0 |
| K243886 | ExpressCore Biopsy Device | Inrad, Inc. | 2025-04-29 | 132 | 0 |
| K243945 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC | 2025-04-24 | 125 | 0 |
| K242128 | Forsvall biopsy needle system for prostate biopsy (Forsvall | Xaga Surgical | 2025-02-27 | 223 | 0 |
| K242322 | Bone Marrow Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-01-24 | 171 | 0 |
| K241793 | Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-01-24 | 217 | 0 |
| K242228 | Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36 | Triopsy Medical, Inc. | 2025-01-10 | 164 | 0 |
| K243095 | Mammotome AutoCore™ Single Insertion Core Biopsy System | Devicor Medical Products, Inc. | 2024-10-29 | 29 | 0 |
| K242029 | TRAP EASY | H.S Hospital Service S.P.A | 2024-10-09 | 90 | 0 |
| K240664 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC | 2024-08-09 | 154 | 0 |
| K233294 | Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM | Itp Innovative Tomography Products GmbH | 2024-06-18 | 263 | 0 |
| K233031 | M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Bio | Canyon Medical, Inc. | 2024-01-17 | 114 | 0 |
| K230646 | SUREcore Prime Biopsy Instrument | Uro-1 Medical, Inc. | 2023-11-29 | 266 | 0 |
| K233220 | EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Br | Senorx, Inc. | 2023-10-27 | 29 | 0 |
| K230015 | OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone | Laurane Medical Sas | 2023-06-16 | 164 | 0 |
| K223300 | Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic B | Geotek Medikal Ltd Sti | 2023-04-21 | 176 | 0 |
| K222865 | M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Bio | Canyon Medical, Inc. | 2023-04-03 | 193 | 0 |
| K223612 | Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BM | Ranfac Corporation | 2023-02-21 | 78 | 0 |
| K222462 | Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Bio | Itp Innovative Tomography Products GmbH | 2023-01-20 | 158 | 0 |
| K220611 | SUREcore Plus Biopsy Instrument | Uro-1, Inc. | 2022-12-02 | 274 | 0 |
| K220595 | NeoNavia Biopsy System | Neodynamics AB | 2022-09-08 | 191 | 0 |
| K212820 | Disposable Semi Automatic Biopsy Instrument | Suzhou Leapmed Healthcare Corporation | 2022-07-06 | 306 | 0 |
| K213232 | NovaCore Semi-Automatic Biopsy Instrument | Argon Medical Devices | 2022-07-01 | 274 | 0 |
| K214063 | Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 | Guangzhou Shengwei Medical Devices Co., Ltd. | 2022-06-03 | 158 | 0 |
| K213683 | Promisemed Fine Biopsy Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2022-04-22 | 151 | 0 |
| K213896 | BD Trek Powered Bone Biopsy System | Bard Peripheral Vascular | 2022-03-30 | 106 | 0 |
| K212079 | TeesuVac Breast Biopsy Device Mark 1 | Teesuvac Aps | 2022-02-02 | 215 | 0 |
| K213213 | Arthrex Vortex Threaded Bone Marrow Recovery Needle | Arthrex, Inc. | 2021-11-19 | 51 | 0 |
| K212284 | Disposable Automatic Core Biopsy Instrument | Suzhou Leapmed Healthcare Corporation | 2021-11-10 | 112 | 0 |
| K203141 | Uramix CuraWay Biopsy Needle | Uramix, Inc. | 2021-09-17 | 332 | 0 |
| K210946 | Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Bio | Promisemed Hangzhou Meditech Co., Ltd. | 2021-08-12 | 135 | 0 |
| K211933 | EleVation Breast Biopsy System | Bard Peripheral Vascular | 2021-07-15 | 23 | 0 |
| K210654 | EnCor Breast Biopsy Probe with Rinse Tube | Senorx, Inc. | 2021-03-31 | 27 | 0 |
| K210631 | Avitus(r) Bone Harvester | Avitus Orthopaedics, Inc. | 2021-03-31 | 28 | 0 |
| K201650 | VMCore Biopsy Needle | Uro-1, Inc. | 2021-01-15 | 211 | 0 |
| K203397 | Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tr | Biopsybell S.R.L. | 2021-01-11 | 54 | 0 |
| K202287 | Ran-Flex-B Bone Marrow Aspiration Needle | Ranfac Corporation | 2020-09-18 | 37 | 0 |
| K201166 | Temno Elite Biopsy System | Merit Medical Systems, Inc. | 2020-08-28 | 119 | 0 |
| K202012 | Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System | Devicor Medical Products, Inc. | 2020-08-18 | 28 | 0 |
| K201244 | Concorde Models Concorde US and Concorde ST Soft Tissue Biop | Transmed7, LLC | 2020-08-07 | 91 | 0 |
| K192101 | Medone Ultra, Medextra | Medax Srl Unipersonale | 2020-04-02 | 241 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda