Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mirco-Tech (Nanjing) Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
121 daysmedian FDA review time
175 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260262 | Injection Needle | Mirco-Tech (Nanjing) Co., Ltd. | 2026-05-29 | 121 | 0 |
| K253832 | Dilation Balloon Catheter | Mirco-Tech (Nanjing) Co., Ltd. | 2026-04-24 | 144 | 0 |
| K254153 | Single-use Video Scope; PB Digital Controller | Mirco-Tech (Nanjing) Co., Ltd. | 2026-04-03 | 102 | 0 |
| K253139 | Disposable Distal Cap | Mirco-Tech (Nanjing) Co., Ltd. | 2026-03-19 | 175 | 0 |
| K233772 | Disposable Dual Action Tissue Closure Device | Mirco-Tech (Nanjing) Co., Ltd. | 2024-03-19 | 116 | 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