510(k) · Cleared
Recalled · 2011Motility Visualization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sierra Scientific Instruments, Inc. · FFX System, Gastrointestinal Motility (Electrical)
Cleared on Dec 12, 2003 as substantially equivalent to K011472 (Medtronic Functional Diagnostics A/S, 2001) after a 242-day review. Its family tree reaches back 1 generation to 2001. 15 later devices descend from it. It has been recalled once.
- Decided
- Dec 12, 2003
- Review
- 242 days
- Class
- Class II
- Product code
- FFX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011472 (2001). 15 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK011472 Polygram 98 Anorectal Function Testing Application, Polygram 98…Medtronic Functional Diagnostics A/S · 2001
- This deviceK031169 Motility Visualization SystemSierra Scientific Instruments, Inc. · 2003
- Descendant · cites it directly · 7 of its ownK120088 Mcompass Anorectal Manometry SystemMedspira, LLC · 2012 · Recalled
- Descendant · 2 generations on · 4 of its ownK161785 THD AnopressThd Spa · 2017
- Descendant · 2 generations on · 3 of its ownK180135 THD Anopress with THD SensyProbeThd Spa · 2018
- Descendant · cites it directly · 2 of its ownK062222 Unitip High Resolution CatheterUnisensor AG · 2007
- Descendant · 2 generations on · 1 of its ownK143031 mcompass Biofeedback Anorectal Manometry SystemMedspira, LLC · 2015 · Recalled
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K120088Mcompass Anorectal Manometry SystemMedspira, LLC · 2012 · cites it directly7descendants
- K161785THD AnopressThd Spa · 2017 · 2 generations on4descendants
- K180135THD Anopress with THD SensyProbeThd Spa · 2018 · 2 generations on3descendants
- K062222Unitip High Resolution CatheterUnisensor AG · 2007 · cites it directly2descendants
- K143031mcompass Biofeedback Anorectal Manometry SystemMedspira, LLC · 2015 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011472 | Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal… | Medtronic Functional Diagnostics A/S | 2001 | — |
| 0 (this device) | K031169 | Motility Visualization System | Sierra Scientific Instruments, Inc. | 2003 | — |
| +1 | K120088 | Mcompass Anorectal Manometry System | Medspira, LLC | 2012 | 1 |
| +2 | K161785 | THD Anopress | Thd Spa | 2017 | — |
| +2 | K180135 | THD Anopress with THD SensyProbe | Thd Spa | 2018 | — |
| +1 | K062222 | Unitip High Resolution Catheter | Unisensor AG | 2007 | — |
| +2 | K143031 | mcompass Biofeedback Anorectal Manometry System | Medspira, LLC | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K011472 | Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal Manometry…Summary page 1…name: Gastrointestinal Motility (Electrical) System Classification: Class II Product Code: FFX Substantial equivalence claimed to: i. K011472 - Medtronic, Polygraf ID and Polygram 98 software Description: The Motility Visualization System (MVS) obtains a high resolutio… | 2001 |
What descends from it? (15)
See all 154 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 12, 2011 | Not classified | Z-0135-2012 | Nonconforming Material/Component | The recall was initiated after Given Imaging received a test report during a Canadian licensing process where the AR ManoShield exhibited pinholes and did not pass the test, the Field Safety Corrective Action (FSCA) Committee was… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
The Motility Visualization System obtains a high resolution mapping of pressures within tubular organs of the gastrointestinal tract. These organs include the esophagus from the pharyngeal region to the stomach, the proximal gut (stomach/duodenum), and the anus/rectum. It is used in a medical clinical setting to sense the pressures and store the corresponding data. The system also provides analysis information. The real time data as well as the analysis information can then be viewed by a physician for diagnostic and analysis purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031169: Motility Visualization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031169
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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