510(k) Report

FDA applicant

Klimamed Technologie Medizingerate GmbH

Roseville, CA2 decisions2002–20040 recalls

FDA records 2 decisions for Klimamed Technologie Medizingerate GmbH (Roseville, CA) from 2002 to 2004: 2 510(k) clearances. All are in product code DWJ (System, Thermal Regulating). Its devices cite 1 predicate, 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, cardiovascular panel, where it files most

How often FDA has decided Klimamed Technologie Medizingerate GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Klimamed Technologie Medizingerate GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Klimamed Technologie Medizingerate GmbH 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 Regulating2decisions

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K011859Klimamed Thermal Mat & Controller 95 and 55 WattsKlimamed Technologie Medizingerate GmbH · 20024cite it
  • K031728Klimamed Thermal Blankets, Including Arm Shoulder West Thermal Blanket and Leg Warmer Thermal BlanketKlimamed Technologie Medizingerate GmbH · 20041cites it

What has FDA decided for it lately?

  • K031728Klimamed Thermal Blankets, Including Arm Shoulder West Thermal Blanket and Leg Warmer Thermal BlanketKlimamed Technologie Medizingerate GmbH · 2004
  • K011859Klimamed Thermal Mat & Controller 95 and 55 WattsKlimamed Technologie Medizingerate GmbH · 2002

All 2 as Klimamed Technologie Medizingerate GmbH →