FDA applicant
Cryogenic Assoc.
FDA records 6 decisions for Cryogenic Assoc. (Walker, MI) from 1980 to 1988: 6 510(k) clearances. Most are in product codes CAW (Generator, Oxygen, Portable) and BYJ (Unit, Liquid-Oxygen, Portable). 4 recalls are linked to its devices, 4 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cryogenic Assoc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Cryogenic Assoc. since 2007.
Recalls per year
4in 2022
Class I Class II/III not classified
Planning a device like Cryogenic Assoc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Cryogenic”
FDA records each applicant name separately; these may or may not be the same firm.