# K192325: Quantum Blood and Fluid Warming System

- Pathway: 510(k) (Special)
- Applicant: Life Warmer, Inc.
- Decided: Oct 18, 2019 after 52 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: 6 generations back to K770232 (1977). 8 ancestors in all.
No later device cites it as a predicate yet.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181775: Quantum Blood and IV Fluid Infusion Warmer, Life Warmer, Inc. (2019) Summary page 4.

## Indications for use
The Quantum™ Blood and Fluid Warming System is indicated for warming blood, blood products and intravenous solutions prior to administration in adult and pediatric patients greater than 28 days old of normal birth weight. It is intended for use by healthcare professionals in hospital, clinical, field, and transport environments to help prevent hypothermia. The Quantum is not for use with neonates (birth to 28 days old) or infants of low birth weight.

Source page: https://510kreport.com/device/K192325
Methodology: https://510kreport.com/methodology