Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Micro-Tech (Nanjing) Co., Ltd. — Predicate Candidate Screening
41 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
171 daysmedian FDA review time
264 days90th percentile
41clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252492 | Visualized Access and Delivery Catheter; PB Digital Controll | Micro-Tech (Nanjing) Co., Ltd. | 2026-04-24 | 259 | 0 |
| K251692 | Advanced Tissue Resection Device | Micro-Tech (Nanjing) Co., Ltd. | 2026-02-21 | 264 | 0 |
| K250229 | Dual Action Tissue Closure Device | Micro-Tech (Nanjing) Co., Ltd. | 2025-09-08 | 224 | 0 |
| K243388 | Disposable Distal Cap | Micro-Tech (Nanjing) Co., Ltd. | 2025-06-27 | 239 | 0 |
| K243471 | Extraction Basket | Micro-Tech (Nanjing) Co., Ltd. | 2024-12-16 | 38 | 0 |
| K230127 | Biliary Plastic Stent, Biliary Plastic Stent Introducer, Bil | Micro-Tech (Nanjing) Co., Ltd. | 2023-09-06 | 232 | 0 |
| K221784 | Single-use Video Pancreaticobiliary Scope, PB Digital Contro | Micro-Tech (Nanjing) Co., Ltd. | 2023-02-16 | 240 | 0 |
| K222354 | Elastic Traction System | Micro-Tech (Nanjing) Co., Ltd. | 2022-10-03 | 60 | 0 |
| K213060 | AreusTM Endobronchial Ultrasound Aspiration Needle, TridentT | Micro-Tech (Nanjing) Co., Ltd. | 2022-07-20 | 301 | 0 |
| K220424 | Through the Scope Tracheal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2022-07-08 | 144 | 0 |
| K220157 | Disposable Hemostatic Closure Clip Device | Micro-Tech (Nanjing) Co., Ltd. | 2022-06-13 | 145 | 0 |
| K211021 | Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval | Micro-Tech (Nanjing) Co., Ltd. | 2022-05-06 | 396 | 0 |
| K220247 | Guidewire Locking Device | Micro-Tech (Nanjing) Co., Ltd. | 2022-03-29 | 60 | 0 |
| K212748 | Disposable Dual Action Tissue Clip | Micro-Tech (Nanjing) Co., Ltd. | 2022-01-20 | 143 | 0 |
| K211172 | Single Use Electrosurgical Knife with Fluid Pump System | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-17 | 242 | 0 |
| K212852 | Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tri | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-06 | 90 | 0 |
| K210934 | Sphincterotome / short-wire compatible, Sterile Sphincteroto | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-01 | 247 | 0 |
| K212403 | Tracheal Stent System (Y-Shaped) | Micro-Tech (Nanjing) Co., Ltd. | 2021-10-30 | 89 | 0 |
| K202204 | Tracheal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2021-09-01 | 392 | 0 |
| K202438 | Ensure Single-Use Coagulation Forceps | Micro-Tech (Nanjing) Co., Ltd. | 2021-03-15 | 202 | 0 |
| K202333 | Lockado Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | 2021-01-14 | 150 | 0 |
| K200071 | Blue Beacon Submucosal Injectable Solution | Micro-Tech (Nanjing) Co., Ltd. | 2020-11-03 | 295 | 0 |
| K193601 | Single Use Electrosurgical Knife | Micro-Tech (Nanjing) Co., Ltd. | 2020-07-24 | 214 | 0 |
| K182910 | Segmented Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2019-05-29 | 224 | 0 |
| K190030 | Embrella Endoscopic Distal Attachment | Micro-Tech (Nanjing) Co., Ltd. | 2019-03-05 | 57 | 0 |
| K182556 | SureClip Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | 2018-12-14 | 88 | 0 |
| K180418 | Reliant(TM) Multistage Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2018-10-15 | 242 | 0 |
| K180018 | Disposable Hot Biopsy Forceps | Micro-Tech (Nanjing) Co., Ltd. | 2018-07-05 | 184 | 0 |
| K180325 | Single Use MultiClip Device | Micro-Tech (Nanjing) Co., Ltd. | 2018-06-01 | 116 | 0 |
| K172813 | Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2018-05-18 | 242 | 0 |
| K172663 | Cytology Brush | Micro-Tech (Nanjing) Co., Ltd. | 2018-03-05 | 181 | 0 |
| K172309 | Endoscopic Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. | 2017-09-29 | 60 | 0 |
| K162226 | Reliant Multistage Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2017-01-25 | 170 | 0 |
| K161463 | SureClip(TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | 2017-01-06 | 225 | 0 |
| K162466 | LuminScan (TM) Imaging System | Micro-Tech (Nanjing) Co., Ltd. | 2016-11-29 | 88 | 0 |
| K160625 | Disposable Hot Biopsy Forceps | Micro-Tech (Nanjing) Co., Ltd. | 2016-06-14 | 102 | 0 |
| K152802 | Grasping Forceps | Micro-Tech (Nanjing) Co., Ltd. | 2016-01-21 | 115 | 0 |
| K152001 | Sterile Repositionable Hemostasis Clipping Device | Micro-Tech (Nanjing) Co., Ltd. | 2015-12-10 | 143 | 0 |
| K151671 | Disposable Multistage Dilation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2015-10-16 | 116 | 0 |
| K150316 | Polypectomy Snare | Micro-Tech (Nanjing) Co., Ltd. | 2015-07-30 | 171 | 0 |
| K150434 | Injection Needle | Micro-Tech (Nanjing) Co., Ltd. | 2015-06-02 | 103 | 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