# K213191: S-Line

- Pathway: 510(k) (Traditional)
- Applicant: Barkey GmbH & Co. KG
- Decided: May 24, 2022 after 237 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: 2 generations back to K954769 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121198: BW685, BW685S, Biegler GmbH (2012) Summary page 4.

## Indications for use
The Barkey S-Line blood / fluid warming system is intended to deliver warm blood, blood products, and liquids to adult and pediatric patients. It delivers the fluid via intravenous (IV) administration in hospitals and clinical settings where warmed intravenous fluids are required.

Source page: https://510kreport.com/device/K213191
Methodology: https://510kreport.com/methodology