Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cryo Corp. — 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) |
|---|---|---|---|---|---|
| K872145 | CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000) | Cryo Corp. | 1987-11-13 | 162 | 0 |
| K834569 | VENTILATORY FREQUENCY MONITOR | Cryo Corp. | 1984-03-30 | 92 | 0 |
| K833994 | PULSAIR I & II | Cryo Corp. | 1983-12-12 | 21 | 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