# K931896: Pro-Flo System

- Pathway: 510(k) (Traditional)
- Applicant: Lafayette Pharmacal, Inc.
- Decided: Aug 26, 1993 after 133 days
- Product code: FCE (Enema Kit)
- Device class: 1
- Regulation: 21 CFR 876.5210
- 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) E-Z-EM BariFlow Model #880: named in the summary without a submission number
- (no number) PerfectView Model #6201: named in the summary without a submission number

## Indications for use
The Pro-Flo System is a remote control device used to control the flow rate of barium sulfate suspension and of air during air contrast x-ray examinations of the lower gastrointestinal tract.

Source page: https://510kreport.com/device/K931896
Methodology: https://510kreport.com/methodology