# K013704: Mediplus Single Use GI Manometry Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Mediplus, Ltd.
- Decided: Aug 5, 2002 after 270 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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) Arndorfer Esophageal Manometry Catheter: named in the summary without a submission number
- (no number) Dentsleeve Manometric Multilumen Extrusion: named in the summary without a submission number

## Most influential descendants
- K032138: Medtronic Single Use Esophageal Manometric Catheter, Medtronic Single Use Anorectal Manometric Catheter (2003), 1 descendant of its own
- 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 GI Manometry Catheter is intended for water-perfused manometry of the GI tract.

Source page: https://510kreport.com/device/K013704
Methodology: https://510kreport.com/methodology