# K031617: Mediplus Single Use Lower GI Manometry Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Mediplus, Ltd.
- Decided: Jan 16, 2004 after 238 days
- Product code: KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube)
- Device class: 2
- Regulation: 21 CFR 876.1725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Medtronic Zinectics anorectal water perfused manometry catheter: named in the summary without a submission number

## Most influential descendants
- K062362: Single Use Esophageal Manometey Catheters and Single Use Ano-Rectal Manometry Catheters (2007), 0 descendants of its own

## Indications for use
The Mediplus single use anorectal GI manometry catheter is intended for use when measurements of gastrointestinal tract pressures are needed to assist in the diagnosis of suspected colonic and anorectal disorders. The product is for use by a trained physician.

Source page: https://510kreport.com/device/K031617
Methodology: https://510kreport.com/methodology