Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oco Biomedical — 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) |
|---|---|---|---|---|---|
| K122198 | 6.00MM X 6.00MM MACRO EXTERNAL IMPLANT SYSTEM | Oco Biomedical | 2013-04-05 | 255 | 0 |
| K110337 | UNIVERSAL MAXILLARY MOLAR | Oco Biomedical | 2012-03-16 | 406 | 0 |
| K090174 | TSI; ERI | Oco Biomedical | 2009-09-14 | 234 | 0 |
| K080115 | I-MINI DENTAL IMPLANT | Oco Biomedical | 2008-05-30 | 135 | 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