510(k) Report

FDA applicant

Inditherm Medical

Minneapolis, MN2 decisions2006–20060 recalls

FDA records 2 decisions for Inditherm Medical (Minneapolis, MN) in 2006: 2 510(k) clearances. All are in product code DWJ (System, Thermal Regulating). Its devices cite 3 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Inditherm Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Inditherm Medical 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

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K051419Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1; PTM1; Otb; RB1Inditherm Medical · 20063cite it

What has FDA decided for it lately?

  • K061902Cosytherm, Models NCM1, NCM2, NCB1, CCU1, CRU1Inditherm Medical · 2006
  • K051419Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1; PTM1; Otb; RB1Inditherm Medical · 2006

All 2 as Inditherm Medical →