# K121198: BW685, BW685S

- Pathway: 510(k) (Traditional)
- Applicant: Biegler GmbH
- Decided: Jul 12, 2012 after 84 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
Longest line of descent: 1 generation back to K954769 (1996). 1 ancestor in all.
1 later device descends 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)
- K954769: Biegler BW385L Blood & Infusion Warmer, Biegler Medical Products, Inc. (1996) Summary page 1.

## Most influential descendants
- K213191: S-Line (2022), 0 descendants of its own

## Indications for use
The BW685/BW685 S blood / fluid warming system is intended to deliver warm blood, blood products, and liquids to adult and pediatric patients.

Source page: https://510kreport.com/device/K121198
Methodology: https://510kreport.com/methodology