Astopad Patient Warming System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K202197 FDA 510(k)
- FDA Product Code
- DWJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5900 FDA 510(k)
- Regulation Number
- 870.5900 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Astopad Patient Warming System is a Thermal Regulating System designed to maintain or restore patient body temperature during medical procedures. It employs conductive heating technology to prevent perioperative hypothermia by transferring heat directly to the patient’s surface, ensuring thermal stability in clinical settings such as operating rooms or recovery areas.
The system is modular, reusable, and intended for use with various patient sizes and conditions. Supplied as a reusable medical device, it requires proper sterilization between uses and is classified under FDA Device Class II and MDD (Medical Device Directive). Authorized under FDA 510K and MDD, it includes multiple configurations (e.g., DUO310, COV070, SOF2) to accommodate different patient needs, with specifications validated for clinical safety and efficacy.
Frequently asked questions
How is the Astopad Patient Warming System intended to be used in clinical settings, and what types of patients can it accommodate?
The Astopad Patient Warming System uses conductive heating technology to maintain or restore patient body temperature during medical procedures, helping prevent perioperative hypothermia. It is designed for use in clinical settings like operating rooms or recovery areas. The system is modular and reusable, with multiple configurations (e.g., DUO310, COV070, SOF2) to accommodate various patient sizes and conditions, ensuring flexibility for different clinical needs.
Is the Astopad Patient Warming System single-use or reusable, and what sterilization process is required between uses?
The Astopad Patient Warming System is a reusable medical device, meaning it must be properly sterilized between uses to ensure safety and hygiene. The manufacturer, Stihler Electronic GmbH, specifies that sterilization is required, though the exact sterilization method (e.g., autoclave, ethylene oxide) is not detailed in the provided data.
What regulatory pathways has the Astopad Patient Warming System followed, and what does this mean for its use in the U.S.?
The Astopad Patient Warming System has been authorized under the FDA’s 510(k) pathway, specifically classified as a Device Class II thermal regulating system. It was determined *substantially equivalent* to a predicate device through a traditional review process by the FDA’s Cardiovascular (CV) Advisory Committee. This means it has met FDA requirements for safety and effectiveness, allowing legal use in the U.S. under the specified indications for thermal regulation.
How do the different configurations (e.g., DUO310, COV070, SOF2) of the Astopad Patient Warming System differ, and which one should I consider for my facility?
The Astopad system offers multiple configurations (like DUO310, COV070, or SOF2) to adapt to different patient needs, such as size, procedure type, or thermal requirements. While the exact specifications of each model aren’t detailed here, the modular design suggests variations in coverage area, heating intensity, or patient positioning compatibility. Facilities should consult the manufacturer’s documentation or a representative to select the appropriate configuration based on their specific clinical workflows and patient demographics.
What storage requirements should I follow for the Astopad Patient Warming System to ensure optimal performance and longevity?
Since the Astopad Patient Warming System is reusable and requires sterilization between uses, storage should follow standard protocols for reusable medical devices. This typically includes keeping the system in a clean, dry environment away from direct sunlight or extreme temperatures to prevent damage to materials or electrical components. The manufacturer’s instructions (not provided here) should specify any additional storage guidelines, such as humidity control or protective packaging.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: STIHLER ELECTRONIC ASTOPAD Instructions For Use Manual, STIHLER ELECTRONIC ASTOPAD DUO310 Instructions For Use Manual, PDF DUO310-NA COV070-NA COV105-NA COV150-NA COV155-NA COV180-NA - Gentherm, PDF ASTOPAD ASTOPAD® PATIENT WARMIN - Duomed
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K202197 | Class II | Active |
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Manufacturer
- Manufacturer
- Stihler Electronic Gmbh
Sources (2)
- FDA 510(k) K202197 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026