Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Acera Surgical, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
277 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251224 | Restrata Soft Tissue Reinforcement (STR) | Acera Surgical, Inc. | 2025-06-20 | 60 | 0 |
| K223725 | Restrata® MiniMatrix | Acera Surgical, Inc. | 2023-05-18 | 156 | 0 |
| K193583 | Restrata® | Acera Surgical, Inc. | 2020-09-25 | 277 | 0 |
| K172603 | Cerafix Dura Substitute | Acera Surgical, Inc. | 2017-11-27 | 89 | 0 |
| K170300 | Restrata Wound Matrix | Acera Surgical, Inc. | 2017-04-26 | 85 | 0 |
| K161278 | Cerafix Dura Substitute | Acera Surgical, Inc. | 2016-08-08 | 94 | 0 |
| K153613 | Cerafix Dura Substitute | Acera Surgical, Inc. | 2016-03-16 | 90 | 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