Modification to Thermal Angel
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K012031 FDA 510(k)
- FDA Product Code
- BSB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.9205 FDA 510(k)
- Regulation Number
- 864.9205 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a modification to the Thermal Angel, classified as a blood warmer that uses non-electromagnetic radiation. It is designed for warming blood and blood products during transfusion or infusion procedures.
The device is supplied as a reusable system and is intended for use in clinical settings such as hospitals and emergency medical services. It has received FDA 510(k) clearance (K012031) and is classified as a Class II medical device under regulation number 864.9205, with product code BSB.
Frequently asked questions
What is the Modification to Thermal Angel used for?
It is designed for warming blood and blood products during transfusion or infusion procedures, using non-electromagnetic radiation to maintain normothermia in clinical settings such as hospitals and emergency medical services.
Is the Modification to Thermal Angel reusable or single-use?
The device is supplied as a reusable system, meaning it can be cleaned and used multiple times following the manufacturer’s reprocessing instructions, rather than being discarded after a single use.
What regulatory clearance does the Modification to Thermal Angel have?
It has received FDA 510(k) clearance under K012031 and is classified as a Class II medical device under regulation 864.9205 with product code BSB, indicating it was found substantially equivalent to a legally marketed predicate device.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K012031 | Class II | Active |
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Manufacturer
- Manufacturer
- Estill Medical Technologies, Inc.
Sources (1)
- FDA 510(k) K012031 24 fields · synced Sep 23, 2026