Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Acro Biomedical Co., Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233378 | ABCcolla® Collagen ADM Scaffold | Acro Biomedical Co., Ltd. | 2024-10-18 | 382 | 0 |
| K212156 | ABCcolla Bone Matrix | Acro Biomedical Co., Ltd. | 2021-10-08 | 88 | 0 |
| K171629 | ABCcolla Bone Graft | Acro Biomedical Co., Ltd. | 2018-02-01 | 244 | 0 |
| K162348 | ABCcolla Collagen Matrix | Acro Biomedical Co., Ltd. | 2017-05-10 | 261 | 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