510(k) Report

FDA applicant

Nuance Medical, LLC

Carlsbad, CA6 decisions2013–20240 recalls

FDA records 6 decisions for Nuance Medical, LLC (Carlsbad, CA) from 2013 to 2024: 6 510(k) clearances. Most are in product codes GEH (Unit, Cryosurgical, Accessories) and MLY (Vapocoolant Device). Its devices cite 8 predicates, 2 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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Nuance Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2013: 12016: 22017: 12021: 12024: 1
2013high 2 (2016) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Nuance Medical, LLC by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nuance Medical, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEHUnit, Cryosurgical, Accessories3decisions
  • MLYVapocoolant Device3decisions

Whose devices does it build on?

Its devices cite 8 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 2 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.

  • K130995Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze SprayNuance Medical, LLC · 20134cite it
  • K162218Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102Nuance Medical, LLC · 20162cite it
  • K161337CryoDose H or SimilarNuance Medical, LLC · 20161cites it
  • K232674PainFreeze IINuance Medical, LLC · 20241cites it

What has FDA decided for it lately?

  • K232674PainFreeze IINuance Medical, LLC · 2024
  • K210310CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister KitNuance Medical, LLC · 2021
  • K172203CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream SprayNuance Medical, LLC · 2017
  • K162218Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102Nuance Medical, LLC · 2016
  • K161337CryoDose H or SimilarNuance Medical, LLC · 2016
  • K130995Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze SprayNuance Medical, LLC · 2013

All 6 as Nuance Medical, LLC →