# K982587: MPS Fixed Flow Rate Set

- Pathway: 510(k) (Traditional)
- Applicant: Medical Product Specialists
- Decided: Aug 24, 1998 after 31 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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. The FDA summary names its predicate without a number.
- (no number) I-Flow® Fixed Flow Rate Gravity Set: named in the summary without a submission number

## Indications for use
1. The MPS Fixed Flow Rate Set is intended for single use in continuous or intermittent infusion therapy. 2. For use for infusion of |.V. fluids and drugs.

Source page: https://510kreport.com/device/K982587
Methodology: https://510kreport.com/methodology