# K983665: Manometric Assemblies

- Pathway: 510(k) (Traditional)
- Applicant: Dentsleeve Pty., Ltd.
- Decided: May 17, 1999 after 210 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.
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 no predicate by number.

## Indications for use
Use of Dentsleeve Manometric Assemblies is indicated when measurements of gastrointestinal tract pressures are judged to be useful for determining management of adults, children & infants with proven or suspected gastrointestinal motor disorders.

Source page: https://510kreport.com/device/K983665
Methodology: https://510kreport.com/methodology