Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aroa Biosurgery , Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
154 daysmedian FDA review time
397 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260669 | Endoform Dermal Template | Aroa Biosurgery , Ltd. | 2026-06-24 | 114 | 0 |
| K250598 | Endoform Reconstructive Template - PLGA | Aroa Biosurgery , Ltd. | 2025-06-03 | 95 | 0 |
| K231305 | Endoform Dental Membrane | Aroa Biosurgery , Ltd. | 2024-01-23 | 263 | 0 |
| K223373 | Enivo™ | Aroa Biosurgery , Ltd. | 2023-04-07 | 154 | 0 |
| K200502 | Myriad Particles | Aroa Biosurgery , Ltd. | 2021-03-31 | 397 | 0 |
| K200413 | Symphony | Aroa Biosurgery , Ltd. | 2020-07-29 | 161 | 0 |
| K183398 | Endoform Restella | Aroa Biosurgery , Ltd. | 2019-04-11 | 125 | 0 |
| K181935 | Endoform Reconstructive Template - Non Absorbable | Aroa Biosurgery , Ltd. | 2018-12-04 | 138 | 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