# K130867: Enflow IV Fluid Warmer Insulated Strap

- Pathway: 510(k) (Special)
- Applicant: Vital Signs, Inc., A GE Healthcare Company
- Decided: Jun 14, 2013 after 78 days
- Product code: LGZ (Warmer, Thermal, Infusion Fluid)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (2 Class I)
- 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.
3 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121775: Enflow IV Fluid Warmer, Enflow Disposable Cartridge, Enflow Controller, Vital Signs, Inc., A GE Healthcare Company (2012) Summary page 1.

## Recalls of this device
- Mar 13, 2019 · Class I · Z-1385-2019: Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
- Mar 13, 2019 · Class I · Z-1386-2019: Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.

## 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/K130867
Methodology: https://510kreport.com/methodology