HotDog Warming Mattress + Return Electrode— 510(k) K230866
Substantially EquivalentAugustine Temperature Management, LLC
FDA 510(k) clearance K230866 for HotDog Warming Mattress + Return Electrode, Substantially Equivalent on 2023-06-29. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code DWJ
view allMore clearances from Augustine Temperature Management, LLC
view allAdverse events under product code DWJ
product code DWJ- Death
- 7
- Injury
- 679
- Malfunction
- 17,477
- Total
- 18,163
Source: openFDA MAUDE database, through . 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 K230866
K-number listed on FDA's recall record- Z-1197-2025 — Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
- Z-1199-2025 — Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia
- Z-1171-2025 — Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.
- Z-1172-2025 — Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K230866.
Data sourced from openFDA. This site is unofficial and independent of the FDA.