# K060537: Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow AC Power Supply, Model 120

- Pathway: 510(k) (Traditional)
- Applicant: Enginivity, LLC
- Decided: Jun 8, 2006 after 100 days
- Product code: LGZ (Warmer, Thermal, Infusion Fluid)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 6 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K770232 (1977). 5 ancestors in all.
12 later devices descend from it; 2 cite it directly.
3 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012031: Modification to Thermal Angel, Estill Medical Technologies, Inc. (2001) Summary page 4.

## Most influential descendants
- K112902: Enflow IV Fluid Warmer (2012), 10 descendants of its own
- 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

## 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.
- Feb 20, 2012 · Class II · Z-1972-2012: The EnFlow Warmer Strap does not meet the requirements of the biocompatibility standard (ISO 10993) for products that may have contact with skin for less than 24 hours.
- Jun 30, 2011 · Not classified · Z-3040-2011: enFlow IV Fluid Warmer may have an issue which results in excessive external surface temperature on the underside of the warmer.
- Jul 15, 2010 · Not classified · Z-2380-2010: The enFlow Disposable IV Fluid/Blood Warmer Cartridge's male luer-lock fitting may be oversized and may not fit properly with standard female luer fittings.
- Mar 23, 2009 · Not classified · Z-2008-2009: 1. Fluid contamination of the electronic circuitry can cause short circuits resulting in permanent fuse failure or localized circuit board overheating with possible smoldering and discoloration. 2. El

## Indications for use
The eFlow 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/K060537
Methodology: https://510kreport.com/methodology