# K012906: Animec, Models AM-2S-4 and AM-2S-5

- Pathway: 510(k) (Special)
- Applicant: Elltec Co., Ltd.
- Decided: Oct 9, 2001 after 41 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The infusion/blood warmer model ANIMEC AM-28 is an electrically powered, dry warmer which supplies external heat to the plastic tubing incorporated in intravenous administration sets for intermittent use and low flow rate applications at 1 to 12ml/min. The AM-2S is available in two sizes: 4mm channel for 1.V. administration sets and a Smm channel for blood administration sets.

Source page: https://510kreport.com/device/K012906
Methodology: https://510kreport.com/methodology