Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cryogenic Assoc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
72 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K883590 | OXYTROL | Cryogenic Assoc. | 1988-11-02 | 72 | 0 |
| K852663 | PORTABLE GASEOUS OXGYEN CONTAINER | Cryogenic Assoc. | 1985-08-29 | 66 | 0 |
| K841808 | STROLLER SPRINT | Cryogenic Assoc. | 1984-05-16 | 15 | 0 |
| K822789 | ROOMATE II | Cryogenic Assoc. | 1982-10-15 | 30 | 0 |
| K800742 | LIBERATOR/STROLLER II SYSTEM | Cryogenic Assoc. | 1980-05-23 | 50 | 4 |
| K801104 | ROOMMATE-OXYGEN CONCENTRATOR | Cryogenic Assoc. | 1980-05-23 | 14 | 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