# K981032: Piv System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Solutions, Inc.
- Decided: Sep 2, 1998 after 167 days
- Product code: LDQ
- 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 Solutions PIV IV Bag Warmer and Pressure Infusor is designed to hold and heat IV fluid bags and maintain temperatures to 98° F ( 3°F). It is also a pressure infusor designed to be inflated to increase pressure on the IV bag to assist the infusion of fluid. Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K981032
Methodology: https://510kreport.com/methodology