Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PKL — Predicate Candidate Screening
63 FDA 510(k) clearances under this product code; the 50 most recent screened below.
159 daysmedian FDA review time
267 days90th percentile
63clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260580 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); | Olympus Medical Systems Corp. | 2026-05-21 | 90 | 0 |
| K252270 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | 2026-04-08 | 261 | 0 |
| K253734 | Taurus Clip | Taurus Endoscopy | 2026-03-12 | 108 | 0 |
| K251562 | OTSCneo System Set (100.03n-14n, 100.27n-31n) | Ovesco Endoscopy AG | 2025-12-18 | 210 | 0 |
| K252271 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | 2025-11-12 | 114 | 0 |
| K250229 | Dual Action Tissue Closure Device | Micro-Tech (Nanjing) Co., Ltd. | 2025-09-08 | 224 | 0 |
| K250842 | PADLOCK CLIP EFTR Kit (00713229) | STERIS Corporation | 2025-04-18 | 29 | 0 |
| K250066 | Resolution Clip (M00522600); Resolution Clip (M00522601); Re | Boston Scientific Corporation | 2025-02-06 | 27 | 0 |
| K241005 | Haemostasis Clips | Jiangxi Zhuoruihua Medical Instrument Co., Ltd. | 2025-01-02 | 265 | 0 |
| K240274 | PADLOCK CLIP EFTR Kit (00713229) | STERIS Corporation | 2024-09-17 | 230 | 0 |
| K241858 | BARS Set (100.60) | Ovesco Endoscopy AG | 2024-08-26 | 60 | 0 |
| K234124 | Single Use Hemoclips | Promisemed Hangzhou Meditech Co., Ltd. | 2024-07-12 | 197 | 0 |
| K232969 | Disposable Hemostatic Clips | Ningbo Xinwell Medical Technology Co., Ltd. | 2024-06-07 | 260 | 0 |
| K240617 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); | Olympus Medical Systems Corp. | 2024-06-03 | 90 | 0 |
| K233772 | Disposable Dual Action Tissue Closure Device | Mirco-Tech (Nanjing) Co., Ltd. | 2024-03-19 | 116 | 0 |
| K232450 | Disposable Hemostatic Clips | Zhejiang Soudon Medical Technology Co., Ltd. | 2024-01-26 | 165 | 0 |
| K231633 | Disposable Hemoclip (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2024-01-11 | 220 | 0 |
| K230004 | Disposable Hemoclip | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2023-07-31 | 209 | 0 |
| K222146 | Disposable Endoscopic Hemoclip | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2023-03-28 | 251 | 0 |
| K213217 | Disposable hemoclip | Beijing Zksk Technology Co., Ltd. | 2022-11-14 | 411 | 0 |
| K222503 | Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA C | Boston Scientific Corporation | 2022-09-14 | 27 | 0 |
| K221124 | MANTIS Clip | Boston Scientific Corporation | 2022-08-04 | 108 | 0 |
| K213143 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | 2022-07-12 | 288 | 0 |
| K213338 | CORE-CLIP | Incore Co., Ltd. | 2022-06-23 | 259 | 0 |
| K220157 | Disposable Hemostatic Closure Clip Device | Micro-Tech (Nanjing) Co., Ltd. | 2022-06-13 | 145 | 0 |
| K212669 | Single Use Hemoclip | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022-05-27 | 277 | 0 |
| K211787 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | 2022-03-03 | 267 | 0 |
| K212748 | Disposable Dual Action Tissue Clip | Micro-Tech (Nanjing) Co., Ltd. | 2022-01-20 | 143 | 0 |
| K212323 | Instinct Plus Endoscopic Clipping Device | Wilson-Cook Medical, Inc. | 2021-08-25 | 30 | 1 |
| K202333 | Lockado Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | 2021-01-14 | 150 | 0 |
| K201808 | X-Tack Endoscopic HeliX Tacking System | Apollo Endosurgery, Inc. | 2020-12-15 | 167 | 2 |
| K201771 | Single Use Rotatable and Repositionable Hemoclip | Anrei Medical (Hangzhou) Co., Ltd. | 2020-10-19 | 112 | 0 |
| K200217 | ClearEndoclip | Finemedix Co., Ltd. | 2020-10-05 | 251 | 0 |
| K193424 | Resolution 360™ ULTRA Clip | Boston Scientific Corporation | 2020-09-01 | 266 | 0 |
| K200684 | gastroduodenal FTRD Set | Ovesco Endoscopy AG | 2020-06-02 | 78 | 0 |
| K192697 | Instinct Plus Endoscopic Clipping Device | Cook Endoscopy | 2020-03-05 | 161 | 0 |
| K192722 | Padlock Clip defect closure system, Padlock Pro-Select defec | STERIS Corporation | 2019-10-24 | 27 | 0 |
| K183309 | stentfix OTSC System Set | Ovesco Endoscopy AG | 2019-10-22 | 327 | 0 |
| K183590 | Single Use Reloadable Clip Applicator, Clip, Long Clip, Shor | Olympus Medical Systems Corp. | 2019-08-01 | 223 | 0 |
| K183021 | ClearEndoclip | Finemedix Co., Ltd. | 2019-06-28 | 239 | 0 |
| K182556 | SureClip Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | 2018-12-14 | 88 | 0 |
| K180325 | Single Use MultiClip Device | Micro-Tech (Nanjing) Co., Ltd. | 2018-06-01 | 116 | 0 |
| K172727 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | 2018-04-16 | 217 | 0 |
| K180689 | Padlock Clip defect closure device; Padlock Clip Pro-Select | STERIS Corporation | 2018-04-12 | 28 | 0 |
| K172762 | Single Use Hemoclip | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2018-03-20 | 188 | 0 |
| K170867 | FTRD System Set | Ovesco Endoscopy AG | 2017-07-25 | 124 | 0 |
| K161463 | SureClip(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | 2017-01-06 | 225 | 0 |
| K153550 | FTRD System Set | Ovesco Endoscopy AG | 2016-10-12 | 306 | 0 |
| K152001 | Sterile Repositionable Hemostasis Clipping Device | Micro-Tech (Nanjing) Co., Ltd. | 2015-12-10 | 143 | 0 |
| K150067 | OTSC Proctology | Ovesco Endoscopy AG | 2015-09-16 | 246 | 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