# K132110: Natus Warmette Blanket and Dual Cabinets

- Pathway: 510(k) (Traditional)
- Applicant: Natus Nicolet Ireland, Ltd.
- Decided: Oct 3, 2013 after 86 days
- Product code: LGZ (Warmer, Thermal, Infusion Fluid)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K993797 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112702: Imperial Surgical LTD. Blankey and Solution Warning Cabinets, Imperial Surgical, Ltd. (2012) Summary page 1.

## Recalls of this device
- Oct 15, 2016 · Class II · Z-0951-2017: The fuse blows during initial power up or after a period of time. This results in a complete loss of power to the Cabinet and in some cases has resulted in the fuse cover for the power inlet melting s

## Indications for use
The Natus Warmette® Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette® Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items.

Source page: https://510kreport.com/device/K132110
Methodology: https://510kreport.com/methodology