Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rapid Diagnostic Laboratories, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
183 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K903909 | BLIND CONTROLS FOR DRUGS OF ABUSE TESTING | Rapid Diagnostic Laboratories, Inc. | 1990-10-26 | 65 | 0 |
| K890030 | NEW LOW LEVEL DRUG MIXTURE CONTROL | Rapid Diagnostic Laboratories, Inc. | 1989-01-23 | 19 | 0 |
| K875216 | HIGH PERFORMANCE CALIBRATORS | Rapid Diagnostic Laboratories, Inc. | 1988-06-22 | 183 | 0 |
| K871694 | HYPERFORMANCE CONTROLS (HP-CONTROLS) | Rapid Diagnostic Laboratories, Inc. | 1987-07-07 | 70 | 0 |
| K863117 | HIGH PERFORMANCE CANNABINOID CONTROLS | Rapid Diagnostic Laboratories, Inc. | 1986-09-25 | 42 | 0 |
| K850139 | COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER | Rapid Diagnostic Laboratories, Inc. | 1985-04-10 | 86 | 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