Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biocompatibles , Ltd. — 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) |
|---|---|---|---|---|---|
| K961232 | 0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCH | Biocompatibles , Ltd. | 1996-06-26 | 89 | 0 |
| K955135 | 0.014 INTERMEDIATE GUIDE WIRE W/PHOSPHORYLCHOLINE POLYMER CO | Biocompatibles , Ltd. | 1996-04-09 | 152 | 0 |
| K952152 | PROCLEAR DAILY WEAR CONTACT LENS | Biocompatibles , Ltd. | 1995-07-27 | 80 | 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