Mirco-Tech (Nanjing) Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Mirco-Tech (Nanjing) Co., Ltd.” (first 2024, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 121 days. Since 2017 the median was 121 days, against 175 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 |
|---|---|---|
| 2024 | 1 | 116 |
| 2025 | 0 | — |
| 2026 | 4 | 132 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Mirco-Tech (Nanjing) Co., Ltd. took a median 121 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 175 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FBN | Choledochoscope And Accessories, Flexible/Rigid | 2 | 2 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| PKL | Hemostatic Metal Clip For The Gi Tract | 1 | 1 |
Review panels
Most recent Mirco-Tech (Nanjing) Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260262 | Injection Needle | FBK | 2026-05-29 | 121 |
| K253832 | Dilation Balloon Catheter | FGE | 2026-04-24 | 144 |
| K254153 | Single-use Video Scope; PB Digital Controller | FBN | 2026-04-03 | 102 |
| K253139 | Disposable Distal Cap | FBN | 2026-03-19 | 175 |
| K233772 | Disposable Dual Action Tissue Closure Device | PKL | 2024-03-19 | 116 |
Recalls
openFDA lists no recalls under a recalling firm named Mirco-Tech (Nanjing) Co., Ltd..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Mirco-Tech (Nanjing) Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Mirco-Tech (Nanjing) Co., Ltd.” (first 2024, latest 2026), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mirco-Tech (Nanjing) Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mirco-Tech (Nanjing) Co., Ltd. is 121 days. Since 2017: 121 days, versus 175 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Mirco-Tech (Nanjing) Co., Ltd.?
The most frequent FDA product codes under this applicant name are FBN (Choledochoscope And Accessories, Flexible/Rigid, 2); FBK (Endoscopic Injection Needle, Gastroenterology-Urology, 1); FGE (Stents, Drains And Dilators For The Biliary Ducts, 1).
Next steps
- See all 5 Mirco-Tech (Nanjing) Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FBN, Mirco-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.