# K091336: Ivnow Modular Fluid Warmer, 120V, Model Ivnow-1, Ivnow-2, Ivnow-3, Ivnow-6, Ivnow Modular Fluid Warmer 230V

- Pathway: 510(k) (Traditional)
- Applicant: Enthermics Medical Systems, Inc.
- Decided: May 7, 2010 after 366 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: 1 generation back to K993797 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012276: TEMP 3, Medical Solutions, Inc. (2001) Summary page 1.
- K993797: EC-7701 Fluid Warming Cabinet, Enthermics Medical Systems, Inc. (2000) Summary page 1.

## Indications for use
The ivNow Modular Fluid Warmer is intended to warm injection / IV and irrigation fluid bags to a predetermined temperature, and once warm, to monitor and control the temperature of the fluid in the bags.

Source page: https://510kreport.com/device/K091336
Methodology: https://510kreport.com/methodology