Micro-Tech (Nanjing) Co., Ltd.: FDA clearances and approvals
Micro-Tech (Nanjing) Co., Ltd. has 41 FDA 510(k) clearances (first 2015, latest 2026), across 22 product codes in 4 review panels. Median 510(k) review time: 171 days. Since 2017 its median was 208 days, against 125 days for all cleared 510(k)s in the same product codes. openFDA lists 3 product recalls by a recalling firm named Micro-Tech (Nanjing) Co., Ltd.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 4 | 130 |
| 2016 | 3 | 102 |
| 2017 | 3 | 170 |
| 2018 | 6 | 182 |
| 2019 | 2 | 140 |
| 2020 | 2 | 254 |
| 2021 | 7 | 202 |
| 2022 | 7 | 144 |
| 2023 | 2 | 236 |
| 2024 | 1 | 38 |
| 2025 | 2 | 232 |
| 2026 | 2 | 262 |
Review time against the same product codes
Since 2017, Micro-Tech (Nanjing) Co., Ltd.'s cleared 510(k)s took a median 208 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 125 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | 8 | 8 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 5 | 5 |
| JCT | Prosthesis, Tracheal, Expandable | 3 | 3 |
| KGE | Forceps, Biopsy, Electric | 3 | 3 |
| ESW | Prosthesis, Esophageal | 2 | 2 |
| FDI | Snare, Flexible | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | 2 | 2 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | 1 | 1 |
Plus 12 more product codes.
Review panels
- Gastroenterology and Urology (34)
- Anesthesiology (3)
- General and Plastic Surgery (3)
- Ear, Nose and Throat (1)
Most recent Micro-Tech (Nanjing) Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252492 | Visualized Access and Delivery Catheter; PB Digital Controller | SHU | 2026-04-24 | 259 |
| K251692 | Advanced Tissue Resection Device | FDI | 2026-02-21 | 264 |
| K250229 | Dual Action Tissue Closure Device | PKL | 2025-09-08 | 224 |
| K243388 | Disposable Distal Cap | FDS | 2025-06-27 | 239 |
| K243471 | Extraction Basket | LQR | 2024-12-16 | 38 |
| K230127 | Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible | FGE | 2023-09-06 | 232 |
| K221784 | Single-use Video Pancreaticobiliary Scope, PB Digital Controller | FBN | 2023-02-16 | 240 |
| K222354 | Elastic Traction System | QSW | 2022-10-03 | 60 |
| K213060 | AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle | KTI | 2022-07-20 | 301 |
| K220424 | Through the Scope Tracheal Stent System | JCT | 2022-07-08 | 144 |
31 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2018-09-20.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Micro-Tech (Nanjing) Co., Ltd.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Micro-Tech (Nanjing) Co., Ltd. have?
Micro-Tech (Nanjing) Co., Ltd. has 41 FDA 510(k) clearances (first 2015, latest 2026), across 22 product codes in 4 review panels.
How long does FDA take to clear Micro-Tech (Nanjing) Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Micro-Tech (Nanjing) Co., Ltd.'s cleared 510(k)s is 171 days. Since 2017: 208 days, versus 125 days for all cleared 510(k)s in the same product codes.
What devices does Micro-Tech (Nanjing) Co., Ltd. make?
Its most frequent FDA product codes are PKL (Hemostatic Metal Clip For The Gi Tract, 8); FGE (Stents, Drains And Dilators For The Biliary Ducts, 5); JCT (Prosthesis, Tracheal, Expandable, 3).
Has Micro-Tech (Nanjing) Co., Ltd. had device recalls?
openFDA lists 3 product recalls in 2 recall events by a recalling firm whose name matches Micro-Tech (Nanjing) Co., Ltd; the most recent began 2018-09-20. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 41 Micro-Tech (Nanjing) Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code PKL, Micro-Tech (Nanjing) Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.