Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MNU — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241932 | OSSIOfiber® Compression Staple | OSSIO , Ltd. | 2024-08-28 | 58 | 0 |
| K233302 | OSSIOfiber® Compression Staple | OSSIO , Ltd. | 2023-11-16 | 48 | 0 |
| K212594 | OSSIOfiber® Staple | OSSIO , Ltd. | 2022-01-21 | 158 | 0 |
| K011172 | ARTHREX BIO-TRANSFIX | Arthrex, Inc. | 2001-06-19 | 63 | 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