# K112902: Enflow IV Fluid Warmer

- Pathway: 510(k) (Traditional)
- Applicant: Vital Signs, Inc.
- Decided: Mar 14, 2012 after 162 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.
10 later devices descend from it; 5 cite it directly.
3 of 17 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.

## Most influential descendants
- K232107: °M Warmer System (2024), 1 descendant of its own
- K211618: Fluido Compact Blood and Fluid Warming System (2023), 1 descendant of its own
- K181775: Quantum Blood and IV Fluid Infusion Warmer (2019), 1 descendant of its own
- K150404: QiF Blood and Fluid Warmer (2016), 1 descendant of its own
- K121775: Enflow IV Fluid Warmer, Enflow Disposable Cartridge, Enflow Controller (2012), 1 descendant of its own

## Indications for use
The enFlow IV Fluid Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

Source page: https://510kreport.com/device/K112902
Methodology: https://510kreport.com/methodology