510(k) Report

FDA applicant

Enthermics Medical Systems, Inc.

Washington, DC4 decisions1997–20130 recalls

FDA records 4 decisions for Enthermics Medical Systems, Inc. (Washington, DC) from 1997 to 2013: 4 510(k) clearances. Most are in product codes LGZ (Warmer, Thermal, Infusion Fluid) and LDQ (Unnamed device). Its devices cite 5 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 hospital panel, where it files most

How often FDA has decided Enthermics Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2010: 12013: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Enthermics Medical Systems, Inc. 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?

  • LGZWarmer, Thermal, Infusion Fluid2decisions
  • LDQUnnamed device1decision
  • DWJSystem, Thermal Regulating1decision

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K993797EC-7701 Fluid Warming CabinetEnthermics Medical Systems, Inc. · 20006cite it

What has FDA decided for it lately?

  • K132202DC Series Fluid Warming Cabinet, DC Series Fluid Warming CabinetEnthermics Medical Systems, Inc. · 2013
  • K091336Ivnow Modular Fluid Warmer, 120V, Model Ivnow-1, Ivnow-2, Ivnow-3, Ivnow-6, Ivnow Modular Fluid Warmer 230VEnthermics Medical Systems, Inc. · 2010
  • K993797EC-7701 Fluid Warming CabinetEnthermics Medical Systems, Inc. · 2000
  • K963731Tru-5000 Thermal Recovery Radiant Heating UnitEnthermics Medical Systems, Inc. · 1997

All 4 as Enthermics Medical Systems, Inc. →