510(k) Report

FDA applicant

Cryogenic Assoc.

Walker, MI6 decisions1980–19884 recalls

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, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

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

2022: 4, 4 Class I
2007high 4 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cryogenic Assoc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Cryogenic”

FDA records each applicant name separately; these may or may not be the same firm.