# K953741: Thermacyl Blood/Fluid Warmer

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jun 26, 1996 after 321 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
Longest line of descent: 1 generation back to K770232 (1977). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K770232: Blood/Fluid Warmer Model DW-1000A, Gorman Rupp Industries (1977) Summary page 2.

## Cited in the summary but kept off the family tree
- K910033: Ubi Magiwel (TM) Ana Quantitative, United Biotech, Inc. (1991). The summary prints BK910033, a CBER number, which our reading took as K910033, FDA’s number for Ubi Magiwel (TM) Ana Quantitative (United Biotech, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Alton Dean blood/fluid warmer”. Kept off the family tree. Summary page 2.

## Indications for use
The ThermaCyl™ blood/fluid warmer is indicated for the warming of blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in clinical environments.

Source page: https://510kreport.com/device/K953741
Methodology: https://510kreport.com/methodology