510(k) Report

FDA applicant

Life Warmer, Inc.

Addison, TX2 decisions2019–20190 recalls

FDA records 2 decisions for Life Warmer, Inc. (Addison, TX) in 2019: 2 510(k) clearances. All are in product code LGZ (Warmer, Thermal, Infusion Fluid). Its devices cite 2 predicates, 1 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 hospital panel, where it files most

How often FDA has decided Life Warmer, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2019: 2
2019high 2 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Life Warmer, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LGZWarmer, Thermal, Infusion Fluid2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K181775Quantum Blood and IV Fluid Infusion WarmerLife Warmer, Inc. · 20191cites it

What has FDA decided for it lately?

  • K192325Quantum Blood and Fluid Warming SystemLife Warmer, Inc. · 2019
  • K181775Quantum Blood and IV Fluid Infusion WarmerLife Warmer, Inc. · 2019

All 2 as Life Warmer, Inc. →