# K031478: Microheater

- Pathway: 510(k) (Traditional)
- Applicant: Belmont Instrument Corp.
- Decided: Jul 2, 2003 after 51 days
- Product code: BSB (Warmer, Blood, Non-Electromagnetic Radiation)
- Device class: 2
- Regulation: 21 CFR 864.9205
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Estill Medical Technologies, Inc. Thermal Angel™ Blood/Fluid Warmer: named in the summary without a submission number

## Indications for use
The Microheater intended use is for warming blood, blood products and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia. The system is not meant for the infusion of drugs, or platelet or granulocyte suspensions.

Source page: https://510kreport.com/device/K031478
Methodology: https://510kreport.com/methodology