# K103801: Hypothermx Intravenous Fluid Warmer

- Pathway: 510(k) (Traditional)
- Applicant: Emit Corporation
- Decided: May 20, 2011 after 143 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: 4 generations back to K770232 (1977). 6 ancestors in all.
No later device cites it as a predicate yet.
2 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060537: Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow AC Power Supply, Model 120, Enginivity, LLC (2006) Summary page 1.
- K012031: Modification to Thermal Angel, Estill Medical Technologies, Inc. (2001) Summary page 1.

## Indications for use
The HypothermX® is intended to warm blood blood products and intravenous solutions prior to administration. The HypothermX® is intended to be used by healthcare professionals in clinical and field environments.

Source page: https://510kreport.com/device/K103801
Methodology: https://510kreport.com/methodology