# K983926: MPS Gravity Flow Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Critical Device Corp.
- Decided: Jan 20, 1999 after 76 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
Longest line of descent: 1 generation back to K852254 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871753: Master Medical Device IS I.V. Stat 2, The Master Medical Corp. (1987) Summary page 1.
- K852254: I.V. Stat Master, The Master Medical Corp. (1985) Summary page 1.

## Indications for use
The MPS Gravity Flow Control Set is intended only for a gravity infusion of L.V. fluids and drugs. The MPS Gravity Flow Control Set maintains a pre-selected flow rate for I.V. fluids and drugs to a patient.

Source page: https://510kreport.com/device/K983926
Methodology: https://510kreport.com/methodology