510(k) Report

FDA applicant

Pintler Medical

Seattle, WA1 decision2012–20121 recall

FDA records 1 decision for Pintler Medical (Seattle, WA) in 2012: 1 510(k) clearance. All are in product code DWJ (System, Thermal Regulating). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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 Pintler Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2012high 1 (2018) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Pintler Medical by year, 2012–2026Sources: 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

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K113705Pintler Patient Warming SystemPintler Medical · 20121 recall

The one decision as Pintler Medical →

What has been recalled?

1 recall linked to its devices; the latest:

  • K113705A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001…Apr 20, 2018Class II