# K181775: Quantum Blood and IV Fluid Infusion Warmer

- Pathway: 510(k) (Traditional)
- Applicant: Life Warmer, Inc.
- Decided: Jan 28, 2019 after 209 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: 5 generations back to K770232 (1977). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112902: Enflow IV Fluid Warmer, Vital Signs, Inc. (2012) Summary page 4.

## Most influential descendants
- K192325: Quantum Blood and Fluid Warming System (2019), 0 descendants of its own

## Indications for use
The Quantum Blood and I'V Fluid Infusion Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration in adult patients. It is intended to be used by healthcare professionals in hospital, clinical, field and transport environments to help prevent hypothenmia.

Source page: https://510kreport.com/device/K181775
Methodology: https://510kreport.com/methodology