Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Purgo Biologics, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
291 daysmedian FDA review time
537 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230305 | THE Graft Collagen | Purgo Biologics, Inc. | 2024-07-24 | 537 | 0 |
| K230091 | THE Cover | Purgo Biologics, Inc. | 2023-10-06 | 267 | 0 |
| K222549 | OpenTex | Purgo Biologics, Inc. | 2023-05-11 | 261 | 0 |
| K191737 | The Graft Bone Substitute | Purgo Biologics, Inc. | 2020-02-14 | 231 | 0 |
| K180992 | Biotex | Purgo Biologics, Inc. | 2019-07-16 | 456 | 0 |
| K173188 | The Graft Natural Bone Substitute | Purgo Biologics, Inc. | 2018-07-20 | 291 | 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