# K121775: Enflow IV Fluid Warmer, Enflow Disposable Cartridge, Enflow Controller

- Pathway: 510(k) (Special)
- Applicant: Vital Signs, Inc., A GE Healthcare Company
- Decided: Nov 28, 2012 after 163 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.
3 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)

## Most influential descendants
- K130867: Enflow IV Fluid Warmer Insulated Strap (2013), 0 descendants 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/K121775
Methodology: https://510kreport.com/methodology