Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
International Biomedical, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022873 | POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (B | International Biomedical, Inc. | 2003-03-21 | 204 | 0 |
| K022876 | MODIFICATION TO INFANT LIFE SUPPORT MODULE-20 | International Biomedical, Inc. | 2002-09-11 | 12 | 0 |
| K955766 | ADULT-PEDIATRIC TRANSPORT SYSTEM | International Biomedical, Inc. | 1996-08-07 | 231 | 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