Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FBK — Predicate Candidate Screening
89 FDA 510(k) clearances under this product code; the 50 most recent screened below.
86 daysmedian FDA review time
254 days90th percentile
89clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260262 | Injection Needle | Mirco-Tech (Nanjing) Co., Ltd. | 2026-05-29 | 121 | 0 |
| K253598 | InjecSURE Injection System | Carbon Medical Technologies, Inc. | 2026-03-31 | 133 | 0 |
| K252021 | Disposable Endoscopic Injection Needles | Changzhou New Med Micro-Medtech Co., Ltd. | 2025-12-02 | 155 | 0 |
| K252247 | Injector Force Max Single Use Injector (NM-400L); Injector F | Olympus Medical Systems Corporation | 2025-10-16 | 90 | 0 |
| K241595 | EzVu Visual Vasopressor injector (EV-19) | Veol Medical Technologies Pvt , Ltd. | 2025-02-27 | 269 | 0 |
| K240675 | Endoscopic Injection Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2024-10-04 | 207 | 0 |
| K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201) | Laborie Medical Technologies, Corp. | 2024-08-27 | 90 | 0 |
| K232200 | Disposable Injection Needles | Ningbo Xinwell Medical Technology Co., Ltd. | 2024-04-12 | 262 | 0 |
| K232826 | Articulator Injection Needle (00711807), Articulator Injecti | Steris | 2024-03-08 | 177 | 0 |
| K232442 | Disposable Endoscope Injection Needles | Zhejiang Soudon Medical Technology Co., Ltd. | 2023-11-09 | 87 | 0 |
| K230925 | Disposable Injection Needle AF series | Alton (Shanghai) Medical Instruments Co., Ltd. | 2023-09-27 | 177 | 0 |
| K222006 | Sclerotherapy & Endoscopic Needles | G-Flex Europe Sprl | 2023-04-03 | 270 | 0 |
| K221054 | CORE-INJECTOR | Incore Co., Ltd. | 2022-12-21 | 254 | 0 |
| K221085 | LiNA OperaScope Needle | Lina Medical Aps | 2022-09-02 | 142 | 0 |
| K220292 | Disposable Endoscope Injection Needle | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-08-19 | 199 | 0 |
| K213914 | Injection Needle | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2022-07-29 | 226 | 0 |
| K213239 | Endoscopic Injection Needle | Beijing Zksk Technology Co., Ltd. | 2022-06-02 | 245 | 0 |
| K212668 | Sclerotherapy Needle | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022-02-23 | 184 | 0 |
| K210917 | Single Use Injection Needle | Anrei Medical (Hangzhou) Co., Ltd. | 2021-05-28 | 60 | 0 |
| K192498 | Single Use Injector | Olympus Medical Systems Corp. | 2020-04-28 | 230 | 0 |
| K190032 | Disposable Sclerotherapy Needle | Hangzhou AGS MedTech Co., Ltd. | 2020-02-27 | 416 | 0 |
| K190829 | Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) | Wilson-Cook Medical Inc./Cook Endoscopy | 2019-12-19 | 262 | 0 |
| K181690 | Clear-Jet Injection Catheter | Finemedix Co., Ltd. | 2018-12-21 | 178 | 0 |
| K180214 | Repris Bladder Injection System | Uro-1, Inc. | 2018-05-03 | 98 | 0 |
| K172227 | Endoscopic Injection Needle | Carbon Medical Technologies, Inc. | 2017-08-23 | 29 | 0 |
| K171602 | Williams Cystoscopic Injection Needle | Cook Incorporated | 2017-07-28 | 57 | 0 |
| K171454 | Interject Injection Therapy Needle Catheter | Boston Scientific Corporation | 2017-07-07 | 51 | 2 |
| K153625 | Single Use Injector NM600/610 | Olympus Medical Systems Corp. | 2016-02-12 | 56 | 0 |
| K151475 | EndoChoice Select Injection Needle | Endochoice, Inc. | 2016-02-08 | 251 | 0 |
| K152035 | iSnare system-Lariat | United States Endoscopy Group, Inc. | 2015-10-15 | 85 | 0 |
| K150434 | Injection Needle | Micro-Tech (Nanjing) Co., Ltd. | 2015-06-02 | 103 | 0 |
| K142144 | DISPOSABLE INJECTION NEEDLE | Wilson Instruments (Shanghai) Company Limited | 2015-01-15 | 163 | 0 |
| K133148 | BIOMARC COAXIAL NEEDLE | Carbon Medical Technologies, Inc. | 2014-05-13 | 208 | 0 |
| K132065 | INJECTION NEEDLE | Endochoice, Inc. | 2014-01-17 | 198 | 0 |
| K121337 | UROPLASTY RIGID ENDOSCPIC NEEDLES | Uroplasty, Inc. | 2012-08-03 | 92 | 0 |
| K113634 | INJEKT CYSTO FLEXIBLE INJECTION NEEDLE | Cook Ireland, Ltd. | 2012-02-14 | 67 | 0 |
| K111495 | COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, G | Wilson-Cook Medical, Inc. | 2011-07-19 | 49 | 0 |
| K092090 | ERBELIFT HAND PUMP AND FLEXIBLE PROBE | Byrne Medical, Inc. | 2009-11-30 | 139 | 0 |
| K090830 | LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDG | Laborie Medical Technologies, Ltd. | 2009-07-21 | 117 | 1 |
| K091391 | UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518 | Uroplasty, Inc. | 2009-06-30 | 50 | 0 |
| K090217 | BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 | Coloplast A/S | 2009-04-23 | 84 | 0 |
| K082319 | INJEKT FILIFORM INJECTION NEEDLE | Cook Urological, Inc. | 2008-09-25 | 43 | 0 |
| K061222 | INJECTRA INJECTION NEEDLE | Medi-Globe Corp. | 2006-07-03 | 62 | 0 |
| K043383 | N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110 | Physion, Inc. | 2005-10-27 | 322 | 0 |
| K051905 | UROPLASTY RIGID ENDOSCOPIC NEEDLE | Uroplasty, Inc. | 2005-08-29 | 46 | 0 |
| K050688 | TEGRESS IMPLANT NEEDLE | C.R. Bard, Inc. | 2005-04-06 | 20 | 0 |
| K042882 | ENTERYX INJECTION CATHETER | Boston Scientific Corp | 2004-11-09 | 21 | 1 |
| K042615 | CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE | Carbon Medical Technologies, Inc. | 2004-11-05 | 42 | 0 |
| K031238 | VARICES NEEDLE | Scandimed. A.S. | 2004-10-04 | 535 | 0 |
| K030451 | CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE | Carbon Medical Technologies, Inc. | 2003-04-30 | 78 | 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