510(k) · Cleared
ClearedMark II/Mark Iii 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 Oct 19, 2001 as substantially equivalent to K980946 (Dentsleeve Pty., Ltd., 1998) after a 29-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Oct 19, 2001
- Review
- 29 days
- Class
- Class II
- Product code
- FFX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980946 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK980946 Mark II CO2 Flush Manometric Perfusion Pump & Mark II Manometric…Dentsleeve Pty., Ltd. · 1998
- This deviceK013154 Mark II/Mark Iii Manometric Perfusion PumpDentsleeve Pty., Ltd. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980946 | Mark II CO2 Flush Manometric Perfusion Pump & Mark II Manometric Perfusion Pump | Dentsleeve Pty., Ltd. | 1998 | — |
| 0 (this device) | K013154 | Mark II/Mark Iii Manometric Perfusion Pump | Dentsleeve Pty., Ltd. | 2001 | — |
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 |
|---|---|---|---|
| * | K980946 | Mark II CO2 Flush Manometric Perfusion Pump & Mark II Manometric Perfusion PumpSummary page 2…F 2 Ko 13 154 Comparison to Predicate Devices The device is equivalent in safety and performance to prior legally marketed devices. In particular it is equivalent to: K980946 — Mark II / Mark I CO2 Flush Manometric Perfusion Pump, manufactured by Dentsleeve Pty Ltd. Recognized Standards The requiremen… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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 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.
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/K013154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013154: Mark II/Mark Iii 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/K013154
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026