# K150484: Penguin In-Line Warmer

- Pathway: 510(k) (Traditional)
- Applicant: Creche Innovations
- Decided: Jul 9, 2015 after 135 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: 2 generations back to K024373 (2003). 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)
- K024373: Modification to Animec, Models AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5, Elltec Co., Ltd. (2003) Summary page 4.
- K122449: Enteral Nutrition Warmer, Acacia, Inc. (2013) Summary page 4.

## Indications for use
The Penguin In-Line Warmer is an electrically powered dry warmer which supplies external heat to the plastic tubing of enteral nutrition administration sets.

Source page: https://510kreport.com/device/K150484
Methodology: https://510kreport.com/methodology