HotDog Warming Mattress + Return Electrode— 510(k) K232627

Name: FDA 510(k) clearance K232627
Creator: U.S. Food and Drug Administration
Published: 2024-04-18

Substantially Equivalent

Augustine Temperature Management, LLC

FDA 510(k) clearance K232627 for HotDog Warming Mattress + Return Electrode, Substantially Equivalent on 2024-04-18. Applicant: Augustine Temperature Management, LLC. Device class: 2.

Clearance details

Applicant: Augustine Temperature Management, LLC
Product code: Code DWJ
Device class: Class 2
Regulation: 21 CFR 870.5900
Advisory panel: Cardiovascular
Date received: 2023-08-29
Decision date: 2024-04-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWJ

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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

More clearances from Augustine Temperature Management, LLC

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K230866 — HotDog Warming Mattress + Return Electrode2023-06-29
K210727 — HotDog Warming Mattress + Return Electrode2022-02-01

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 →

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