Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Cryosan, Inc. — Predicate Candidate Screening

6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

38 daysmedian FDA review time
93 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K831953INFUSION PUMPCryosan, Inc.1983-07-19340
K830831AUTOMATED BLOOD CELL SEPARATORCryosan, Inc.1983-06-16920
K822521AUTOMATED BLOOD CELL SEPARATORCryosan, Inc.1982-09-30380
K813489ROCKING/CIRCULATING CYTO-THERM II 3570Cryosan, Inc.1982-03-04930
K812311CIRCULATING CYTO-THERMSCryosan, Inc.1981-09-16300
K812309CRYOSAN NORMAL SALINECryosan, Inc.1981-09-16300

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