Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Microware Precision Co., Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
380 daysmedian FDA review time
450 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242814 | Tandry Q-Locking Plate System | Microware Precision Co., Ltd. | 2024-11-14 | 57 | 0 |
| K230690 | Tandry Locking Plate System | Microware Precision Co., Ltd. | 2023-08-17 | 157 | 0 |
| K220360 | Tandry CMF Plate System | Microware Precision Co., Ltd. | 2022-11-10 | 275 | 0 |
| K220359 | Tandry Compression Screw System | Microware Precision Co., Ltd. | 2022-09-20 | 224 | 0 |
| K182929 | BIO-RAY A-1 Anchor Screw System | Microware Precision Co., Ltd. | 2019-11-06 | 380 | 0 |
| K171904 | Tandry Locking Plate System | Microware Precision Co., Ltd. | 2018-09-18 | 449 | 0 |
| K111008 | MICROWARE BONE PLATES AND BONE SCREW | Microware Precision Co., Ltd. | 2012-05-02 | 387 | 0 |
| K072562 | MICROWARE BONE PLATES AND BONE SCREWS | Microware Precision Co., Ltd. | 2008-12-04 | 450 | 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