# K013154: Mark II/Mark Iii Manometric Perfusion Pump

- Pathway: 510(k) (Special)
- Applicant: Dentsleeve Pty., Ltd.
- Decided: Oct 19, 2001 after 29 days
- Product code: FFX (System, Gastrointestinal Motility (Electrical))
- 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 K980946 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980946: Mark II CO2 Flush Manometric Perfusion Pump & Mark II Manometric Perfusion Pump, Dentsleeve Pty., Ltd. (1998) Summary page 2.

## Indications for use
When used in conjunction with a gastrointestinal manometric assembly (catheter), the Manometric Perfusion Pump can be used where gastrointestinal manometry is indicated when the following conditions are satisfied: 1) When information about patterns of gastrointestinal pressures is judged to be of importance for either determining appropriate patient management or for research studies into gastrointestinal motility. 2) Contraindications are considered, and the risk-benefit analysis is judged to favor performance of the manometric study, after measures have been taken to minimize all possible risks.

Source page: https://510kreport.com/device/K013154
Methodology: https://510kreport.com/methodology