510(k) Report

FDA applicant

Cryoscience North America, Inc.

Houston, TX1 decision2022–20220 recalls

FDA records 1 decision for Cryoscience North America, Inc. (Houston, TX) in 2022: 1 510(k) clearance. All are in product code MLY (Vapocoolant Device). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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

How often FDA has decided Cryoscience North America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Cryoscience North America, Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MLYVapocoolant Device1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K203661CRYO Arctic, CRYO PenguinCryoscience North America, Inc. · 2022

The one decision as Cryoscience North America, Inc. →