Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
California Laboratories, 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) |
|---|---|---|---|---|---|
| K884431 | HEXASCAN HANDPIECE FOR ARGON/DYE LASER | California Laboratories, Inc. | 1988-12-02 | 42 | 0 |
| K884694 | MQL 20 ND:YAG OPHTHALMIC LASER | California Laboratories, Inc. | 1988-11-30 | 21 | 0 |
| K883270 | IRIS ND:YAG OPTHALMIC LASER | California Laboratories, Inc. | 1988-10-13 | 71 | 0 |
| K875338 | CHRYS(TM) MODEL MED-MAX | California Laboratories, Inc. | 1988-04-13 | 105 | 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