# K032138: Medtronic Single Use Esophageal Manometric Catheter, Medtronic Single Use Anorectal Manometric Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Oct 9, 2003 after 90 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
Longest line of descent: 1 generation back to K884527 (1989). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884527: Zinetics (R) Emc, Zinetics Medical, Inc. (1989) Summary page 1.
- K921682: Zinetics Amc, Zinetics Medical, Inc. (1994) Summary page 1.
- K013704: Mediplus Single Use GI Manometry Catheter, Mediplus, Ltd. (2002) Summary page 2.
- K022023: Compass Esophageal Pressure Catheter, Model Gie-8500, Compass Ano-Rectal Pressure Catheter, Model Gia-8500, Clinical Innovations, Inc. (2003) Summary page 1.

## 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 Medtronic Single Use Esophageal Manometric Catheter is intended for water-perfused manometry of the GI tract The Medtronic Single Use Anorectal Manometric Catheter is intended for water-perfused manometry of the rectal and anal canal.

Source page: https://510kreport.com/device/K032138
Methodology: https://510kreport.com/methodology