# K122449: Enteral Nutrition Warmer

- Pathway: 510(k) (Traditional)
- Applicant: Acacia, Inc.
- Decided: Jun 13, 2013 after 304 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 K024373 (2003). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024373: Modification to Animec, Models AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5, Elltec Co., Ltd. (2003) Summary page 1.

## Most influential descendants
- K150484: Penguin In-Line Warmer (2015), 0 descendants of its own

## Indications for use
The Enteral Nutrition Warmer is an electronically powered dry warmer, which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate applications at 0 to 7mL/min.

Source page: https://510kreport.com/device/K122449
Methodology: https://510kreport.com/methodology