# K981509: Tempo Iii

- Pathway: 510(k) (Traditional)
- Applicant: Medical Products, Inc.
- Decided: Jul 10, 1998 after 73 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. (MPI) Tempo III warmer is designed to store and warm I.V. fluid bags/bottles prior to their use. Warning: The facility should contact the manufacturer of the products to be placed inside the Tempo III warmer, and obtain guidelines for exposing their product to temperatures other than those stated on the bag or bottle.

Source page: https://510kreport.com/device/K981509
Methodology: https://510kreport.com/methodology