510(k) Report

FDA applicant

Cryonic Medical North America

Montecito, CA1 decision2003–20030 recalls

FDA records 1 decision for Cryonic Medical North America (Montecito, CA) in 2003: 1 510(k) clearance. All are in product code MLY (Vapocoolant Device). Its devices cite 1 predicate, 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 Cryonic Medical North America’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cryonic Medical North America since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cryonic Medical North America by year, 2007–2026Sources: 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 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K030281Cryotron 2 Cryotherapy DeviceCryonic Medical North America · 20032cite it

What has FDA decided for it lately?

  • K030281Cryotron 2 Cryotherapy DeviceCryonic Medical North America · 2003

The one decision as Cryonic Medical North America →