# K120860: Infu Box Type 0412A

- Pathway: 510(k) (Traditional)
- Applicant: Medical Rescue Equipment Holding AS
- Decided: May 8, 2012 after 47 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: 3 generations back to K770232 (1977). 9 ancestors in all.
No later device cites it as a predicate yet.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060851: Soft Sack IV Fluid Warmer, the Floormount IV Fluid Warmer, the Pak 2 IV Warmer and the Thermal Sac Pressure Infuser, The Smithworks Company (2006) Summary page 1.
- K973741: Bair Hugger Blood/Fluid Warmer, Augustine Medical, Inc. (1998) Summary page 1.

## Indications for use
The INFU Box is indicated for the regulation of temperature of intravenous (IV) fluids bags prior to administration. The device is intended for bags with crystalloid fluids only. Intended users are health care professionals. The device is intended for use in clinical and field environments and is intended to be mounted in a ground based field operating vehicle, such as ambulance or military vehicle.

Source page: https://510kreport.com/device/K120860
Methodology: https://510kreport.com/methodology