# K980946: Mark II CO2 Flush Manometric Perfusion Pump & Mark II Manometric Perfusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Dentsleeve Pty., Ltd.
- Decided: Jun 8, 1998 after 87 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) The Pneumo-Hydraulic Capillary Infusion System: named in the summary without a submission number

## Most influential descendants
- K013154: Mark II/Mark Iii Manometric Perfusion Pump (2001), 0 descendants of its own

## Indications for use
When used in conjunction with a gastrointestinal manometric assembly (catheter), the Mark II CO2 Manometric Perfusion Pump & Mark II Manometric Perfusion Pump, can be used where gastrointestinal manometry is indicated when the following conditions are satisfied; 1) When information about patteras of gastrointestinal pressures is judged to be of importance for either determining appropriate patient n?anagement or for research stud%&s into gastro-intestinal motility. 2) Contra-indications are considered, and the risk-benefit analysis is judged to favour performance of the manometric study, after measures have heen taken to minimise all possible nisks.

Source page: https://510kreport.com/device/K980946
Methodology: https://510kreport.com/methodology