Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
California Medical Laboratories, 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) |
|---|---|---|---|---|---|
| K000830 | CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE | California Medical Laboratories, Inc. | 2000-09-07 | 177 | 0 |
| K993818 | ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESS | California Medical Laboratories, Inc. | 2000-02-08 | 90 | 0 |
| K982891 | CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGI | California Medical Laboratories, Inc. | 1998-09-30 | 44 | 10 |
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