Microware Precision Co., Ltd.: FDA clearances and approvals
Microware Precision Co., Ltd. has 8 FDA 510(k) clearances (first 2008, latest 2024), across 4 product codes in 2 review panels. Median 510(k) review time: 328 days. Since 2017 its median was 250 days, against 103 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 387 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 449 |
| 2019 | 1 | 380 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 250 |
| 2023 | 1 | 157 |
| 2024 | 1 | 57 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Microware Precision Co., Ltd.'s cleared 510(k)s took a median 250 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 5 | 5 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| JEY | Plate, Bone | 1 | 1 |
| OAT | Implant, Endosseous, Orthodontic | 1 | 1 |
Review panels
- Orthopedic (6)
- Dental (2)
Most recent Microware Precision Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242814 | Tandry Q-Locking Plate System | HRS | 2024-11-14 | 57 |
| K230690 | Tandry Locking Plate System | HRS | 2023-08-17 | 157 |
| K220360 | Tandry CMF Plate System | JEY | 2022-11-10 | 275 |
| K220359 | Tandry Compression Screw System | HWC | 2022-09-20 | 224 |
| K182929 | BIO-RAY A-1 Anchor Screw System | OAT | 2019-11-06 | 380 |
| K171904 | Tandry Locking Plate System | HRS | 2018-09-18 | 449 |
| K111008 | MICROWARE BONE PLATES AND BONE SCREW | HRS | 2012-05-02 | 387 |
| K072562 | MICROWARE BONE PLATES AND BONE SCREWS | HRS | 2008-12-04 | 450 |
Recalls
openFDA lists no recalls under a recalling firm named Microware Precision Co., Ltd..
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.
Frequently asked questions
How many FDA 510(k) clearances does Microware Precision Co., Ltd. have?
Microware Precision Co., Ltd. has 8 FDA 510(k) clearances (first 2008, latest 2024), across 4 product codes in 2 review panels.
How long does FDA take to clear Microware Precision Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Microware Precision Co., Ltd.'s cleared 510(k)s is 328 days. Since 2017: 250 days, versus 103 days for all cleared 510(k)s in the same product codes.
What devices does Microware Precision Co., Ltd. make?
Its most frequent FDA product codes are HRS (Plate, Fixation, Bone, 5); HWC (Screw, Fixation, Bone, 1); JEY (Plate, Bone, 1).
Has Microware Precision Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Microware Precision Co., Ltd. Related entities may recall under other names.
Next steps
- See all 8 Microware Precision Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Microware Precision 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.