# K954769: Biegler BW385L Blood & Infusion Warmer

- Pathway: 510(k) (Traditional)
- Applicant: Biegler Medical Products, Inc.
- Decided: Aug 8, 1996 after 297 days
- Product code: LGZ (Warmer, Thermal, Infusion Fluid)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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) DW1000 (Baxter): named in the summary without a submission number
- (no number) Hotline (Level 1): named in the summary without a submission number
- (no number) FloTem (DataChem): named in the summary without a submission number
- (no number) Fenwal (Baxter): named in the summary without a submission number

## Most influential descendants
- K121198: BW685, BW685S (2012), 1 descendant of its own
- K213191: S-Line (2022), 0 descendants of its own

## Indications for use
The Biegler BW385L Blood & Infusion Warmer is designed to reduce complications associated with the infusion of blood and other liquids that are cooler than normal body temperature.

Source page: https://510kreport.com/device/K954769
Methodology: https://510kreport.com/methodology