PINTLER PATIENT WARMING SYSTEM— 510(k) K113705

Name: FDA 510(k) clearance K113705
Creator: U.S. Food and Drug Administration
Published: 2012-08-31

Substantially Equivalent

Pintler Medical

FDA 510(k) clearance K113705 for PINTLER PATIENT WARMING SYSTEM, Substantially Equivalent on 2012-08-31. Applicant: Pintler Medical. Device class: 2.

Clearance details

Applicant: Pintler Medical
Product code: Code DWJ
Device class: Class 2
Regulation: 21 CFR 870.5900
Advisory panel: Cardiovascular
Date received: 2011-12-16
Decision date: 2012-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWJ

view all

K262089 — Disposable Warming Blanket2026-08-21
K261437 — Mistral-Air® Warming System2026-08-07
K260278 — ThermAffyx(TM) Patient Safety System2026-07-08
K260903 — Hot Pink Pad Warming System2026-04-16
K252861 — Warming System2026-04-07

Adverse events under product code DWJ

product code DWJ

Death: 7
Injury: 679
Malfunction: 17,477
Total: 18,163

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K113705

K-number listed on FDA's recall record

Z-1139-2019 — A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocolClass II·Completed·Pintler Medical LLC·20180420

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113705.

Data sourced from openFDA. This site is unofficial and independent of the FDA.