510(k) · Cleared
ClearedMark II CO2 Flush Manometric Perfusion Pump & Mark II Manometric Perfusion Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsleeve Pty., Ltd. · FFX System, Gastrointestinal Motility (Electrical)
Cleared on Jun 8, 1998 after an 87-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jun 8, 1998
- Review
- 87 days
- Class
- Class II
- Product code
- FFX
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK980946 Mark II CO2 Flush Manometric Perfusion Pump & Mark II Manometric…Dentsleeve Pty., Ltd. · 1998
- Descendant · cites it directly · 0 of its ownK013154 Mark II/Mark Iii Manometric Perfusion PumpDentsleeve Pty., Ltd. · 2001
Most influential descendants
Showing 1 of 1 · See all- K013154Mark II/Mark Iii Manometric Perfusion PumpDentsleeve Pty., Ltd. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980946 | Mark II CO2 Flush Manometric Perfusion Pump & Mark II Manometric Perfusion Pump | Dentsleeve Pty., Ltd. | 1998 | — |
| +1 | K013154 | Mark II/Mark Iii Manometric Perfusion Pump | Dentsleeve Pty., Ltd. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FFX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FFX device
- #1 K262621 Rapid Barostat Bag (RBB) Pump and Catheter…score 12.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | The Pneumo-Hydraulic Capillary Infusion System Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013154 | Mark II/Mark Iii Manometric Perfusion Pump | 2001 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K013154 (Dentsleeve Pty., Ltd., 2001) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FFX devicesFFX System, Gastrointestinal Motility (Electrical): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FFX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FFX
123in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FFX
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FFX
32in 2025
MAUDE reports naming product code FFX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 1 | 2 |
| 2010 | 2 | — | 0 | 6 |
| 2011 | 0 | — | 1 | 6 |
| 2012 | 4 | 120 | 0 | 4 |
| 2013 | 1 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 3 | 145 | 0 | 15 |
| 2017 | 2 | — | 0 | 10 |
| 2018 | 1 | — | 0 | 17 |
| 2019 | 4 | 240 | 0 | 27 |
| 2020 | 1 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 26 |
| 2022 | 0 | — | 0 | 31 |
| 2023 | 3 | 123 | 0 | 51 |
| 2024 | 1 | — | 0 | 59 |
| 2025 | 1 | — | 0 | 32 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980946 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980946: Mark II CO2 Flush Manometric Perfusion Pump & Mark II Manometric Perfusion Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980946
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026