Micro-Tech (Nanjing) Co., Ltd.: FDA filings under this applicant name
FDA lists 41 510(k) clearances under the applicant name “Micro-Tech (Nanjing) Co., Ltd.” (first 2015, latest 2026), across 22 product codes in 4 review panels. Median 510(k) review time under this name: 171 days. Since 2017 the median was 208 days, against 125 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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, 510(k)s cleared under the name Micro-Tech (Nanjing) Co., Ltd. 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 applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Micro-Tech (Nanjing) Co., Ltd. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Micro Media Laboratories (52 510(k)s)
- Micro Therapeutics, Inc. (51 510(k)s)
- Micro-Aire Surgical Instruments, Inc. (40 510(k)s)
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (32 510(k)s)
- Micro Surgical Instruments Corp. (15 510(k)s)
- Micro Motors, Inc. (14 510(k)s)
- Micro Detect, Inc. (11 510(k)s)
- Micro-Mega Societe Anonyme (11 510(k)s)
- Micro-Bio-Logics (9 510(k)s)
- Micro Direct, Inc. (9 510(k)s)
- Micro Current Technology, Inc. (8 510(k)s)
- Micro-Medical Devices, Inc. (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Micro-Tech (Nanjing) Co., Ltd.?
FDA lists 41 510(k) clearances under the applicant name “Micro-Tech (Nanjing) Co., Ltd.” (first 2015, latest 2026), across 22 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Micro-Tech (Nanjing) Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Micro-Tech (Nanjing) Co., Ltd. is 171 days. Since 2017: 208 days, versus 125 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Micro-Tech (Nanjing) Co., Ltd.?
The most frequent FDA product codes under this applicant name 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).
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. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.