Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Maxigen Biotech, Inc. — 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) |
|---|---|---|---|---|---|
| K242100 | SurgiAid Collagen Wound Dressing (HA) | Maxigen Biotech, Inc. | 2025-10-16 | 455 | 0 |
| K230529 | HealiAid Dental Collagen Wound Dressing | Maxigen Biotech, Inc. | 2023-11-22 | 268 | 0 |
| K223126 | SurgiAid® Collagen Wound Dressing | Maxigen Biotech, Inc. | 2023-10-11 | 373 | 0 |
| K100927 | SURGIAID | Maxigen Biotech, Inc. | 2011-02-02 | 303 | 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