# K973748: Tempo and Temp H20

- Pathway: 510(k) (Traditional)
- Applicant: Smith
- Decided: Mar 10, 1998 after 160 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 Medical Products, Inc. TempO™ and TempO II™ warming cabinets are design to store and warm LV. fluid bags/bottles, irrigation solution bags/bottles, blankets, towels, etc. prior to their use. Warning: The facility should contact the manufacturer of the products to be place inside the warming cabinet and obtain guidelines for exposing their product to temperatures other than those stated on the bags or bottles.

Source page: https://510kreport.com/device/K973748
Methodology: https://510kreport.com/methodology