HotDog Warming Mattress + Return Electrode— 510(k) K210727
Substantially EquivalentAugustine Temperature Management, LLC
FDA 510(k) clearance K210727 for HotDog Warming Mattress + Return Electrode, Substantially Equivalent on 2022-02-01. Applicant: Augustine Temperature Management, LLC. Device class: 2.
Clearance details
- Applicant
- Augustine Temperature Management, LLC
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Minneapolis, MN, US
Recent devices under product code GEI
view allMore clearances from Augustine Temperature Management, LLC
view allAdverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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 K210727
K-number listed on FDA's recall record- 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 K210727.
Data sourced from openFDA. This site is unofficial and independent of the FDA.