Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Catalyst Research Corp. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
37 daysmedian FDA review time
181 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K905310 | MINIOX V PULSE OXIMETER | Catalyst Research Corp. | 1991-05-28 | 181 | 0 |
| K874132 | MINIOX IV PORTABLE PULSE OXIMETER | Catalyst Research Corp. | 1988-01-19 | 98 | 0 |
| K862798 | MINIOX 100 PULSE OXIMETER | Catalyst Research Corp. | 1986-08-28 | 36 | 0 |
| K833995 | MINI OX II | Catalyst Research Corp. | 1983-12-12 | 21 | 0 |
| K833326 | MINI OX III OXYGEN MONITOR | Catalyst Research Corp. | 1983-11-03 | 37 | 0 |
| K790784 | MODEL M25R, OXYGEN ANALYZER | Catalyst Research Corp. | 1979-04-27 | 4 | 0 |
| K790785 | MODEL M25RL, (CRC) OXYGEN ANALYZER | Catalyst Research Corp. | 1979-04-27 | 4 | 0 |
| K782062 | ANALYZER, OXYGEN MODEL M25RA & M25RAD | Catalyst Research Corp. | 1979-02-15 | 70 | 0 |
| K781746 | MINICO | Catalyst Research Corp. | 1978-12-05 | 48 | 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