# K062362: Single Use Esophageal Manometey Catheters and Single Use Ano-Rectal Manometry Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Sarmed Srl
- Decided: Apr 13, 2007 after 242 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: 2 generations back to K884527 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032138: Medtronic Single Use Esophageal Manometric Catheter, Medtronic Single Use Anorectal Manometric Catheter, Medtronic Vascular (2003) Summary page 1.
- K031617: Mediplus Single Use Lower GI Manometry Catheter, Mediplus, Ltd. (2004) Summary page 1.
- K013704: Mediplus Single Use GI Manometry Catheter, Mediplus, Ltd. (2002)

## Indications for use
The SarMed Single Use Esophageal Manometry Catheters and Ano-Rectal Manometry Catheters are indicated for patients where Gastro-Intestinal and Ano-Rectal tracts pressure measurements are required, such as for detection of GI tract disorders. The products are to be used by a trained physician.

Source page: https://510kreport.com/device/K062362
Methodology: https://510kreport.com/methodology