Hot Dog Patient Warming System
by Augustine Biomedical & Design, LLC 510(k)
Active
510(k) K052392
Overview
The HotDog Patient Warming System is a reusable thermal regulating device designed to maintain patient normothermia during medical procedures. It employs conductive polymer fabric technology to deliver controlled warming without forced air or water, reducing risks associated with traditional warming methods.
This system consists of a central temperature management controller and multiple warming devices, including blankets and mattresses, powered by low-voltage current. Intended for perioperative use in clean surgical environments, it has received FDA 510(k) clearance under the Cardiovascular advisory committee and is regulated under regulation number 870.5900.
HotDog Patient Warming System
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK052392 | Date4 May 2006 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DWJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5900
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Augustine Biomedical & Design, LLC
Questions
What is the HotDog Patient Warming System used for?
The HotDog Patient Warming System is designed to maintain patient normothermia (normal body temperature) during medical procedures, particularly in perioperative settings like clean surgical environments. It prevents unintended hypothermia by delivering controlled, consistent warmth through conductive polymer fabric technology, reducing the risks associated with traditional warming methods like forced air or water-based systems.
How is the HotDog Patient Warming System supplied?
The system consists of a reusable central temperature management controller paired with multiple warming devices, including blankets and mattresses. These components are powered by low-voltage current, ensuring safe and efficient thermal regulation without the need for disposable consumables or complex infrastructure.
Is the HotDog Patient Warming System single-use or reusable?
The HotDog Patient Warming System is designed for reuse. The conductive polymer fabric technology and central controller are built to withstand repeated use in clean surgical environments, making it a cost-effective solution for long-term clinical applications.
What types of warming devices are included in the system?
The system includes multiple warming devices tailored for perioperative use, such as blankets and mattresses. These devices are engineered to conform to patient anatomy while delivering precise, localized warmth without forced air or water, ensuring comfort and safety during procedures.
How should the HotDog Patient Warming System be stored?
The reusable components of the HotDog Patient Warming System should be stored in a clean, dry environment to prevent contamination or damage. Follow manufacturer guidelines for cleaning and maintenance between uses, particularly for the conductive polymer fabric and controller, to ensure optimal performance and longevity.