FDA applicant

Cincinnati Sub-Zero

Walker, MI2 decisions1981–19812 recalls

FDA records 2 decisions for Cincinnati Sub-Zero (Walker, MI) in 1981: 2 510(k) clearances. All are in product code DWJ (System, Thermal Regulating). 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

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

How often FDA has decided Cincinnati Sub-Zero’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cincinnati Sub-Zero since 2007.

Recalls per year

2in 2011

2007high 2 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Cincinnati”

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

Cincinnati Sub-Zero Products, Inc. 12 Cincinnati Medical Technologies, Inc. 1

Cincinnati Sub-Zero

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Cincinnati”