510(k) Report

FDA applicant

Advanced Warming Systems, Inc.

Lubbock, TX3 decisions1991–19960 recalls

FDA records 3 decisions for Advanced Warming Systems, Inc. (Lubbock, TX) from 1991 to 1996: 3 510(k) clearances. Most are in product codes DWJ (System, Thermal Regulating) and CBN (Apparatus, Gas-Scavenging). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Advanced Warming Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advanced Warming 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?

  • DWJSystem, Thermal Regulating1decision
  • CBNApparatus, Gas-Scavenging1decision
  • BSJMask, Gas, Anesthetic1decision

Who builds on its devices?

Later devices cite its devices 4 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.

  • K950771Disposable Adhesive Face MaskAdvanced Warming Systems, Inc. · 19952cite it
  • K913016WarmtouchAdvanced Warming Systems, Inc. · 19911cites it
  • K953269Safecircuit Manifold/Pulmonary UnitAdvanced Warming Systems, Inc. · 19961cites it

What has FDA decided for it lately?

  • K953269Safecircuit Manifold/Pulmonary UnitAdvanced Warming Systems, Inc. · 1996
  • K950771Disposable Adhesive Face MaskAdvanced Warming Systems, Inc. · 1995
  • K913016WarmtouchAdvanced Warming Systems, Inc. · 1991

All 3 as Advanced Warming Systems, Inc. →