Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cooper Medical Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
172 daysmedian FDA review time
202 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K840144 | YAG LASER 8000 GASTROINTESTINAL BLEE | Cooper Medical Corp. | 1984-05-18 | 126 | 0 |
| K833387 | ARGON LASER SURGICAL SYSTEM 770 | Cooper Medical Corp. | 1984-04-18 | 202 | 0 |
| K833497 | COOPER MEDICAL MODEL 770 | Cooper Medical Corp. | 1984-04-17 | 189 | 0 |
| K832703 | ARGON LASER SYS-MODEL 5000 | Cooper Medical Corp. | 1984-01-30 | 172 | 0 |
| K820261 | MONITOR CO2 LASER SYSTEM | Cooper Medical Corp. | 1982-03-05 | 31 | 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