510(k) · Cleared
ClearedSphincter of Oddi Manometric (Som) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mui Scientific · FFX System, Gastrointestinal Motility (Electrical)
Cleared on Jun 21, 2012 after a 120-day review. The FDA summary names its predicate without a number.
- Decided
- Jun 21, 2012
- Review
- 120 days
- Class
- Class II
- Product code
- FFX
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (4)
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 |
|---|---|---|---|
| * | — | Mui Scientific's pressurized infusion pump Named without a submission number | |
| * | — | Mui Scientific's (formerly Dentsleeve Pty) manometric perfusion pump and manometric… Named without a submission number | |
| * | — | Arndorfer Inc's pneumo-hydraulic capillary infusion system and ERCP manometric catheters Named without a submission number | |
| * | — | Cook Medical's Lehman Sphincter of Oddi Manometric catheter Named without a submission number |
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.
How does its category compare?
All FFX devicesFFX System, Gastrointestinal Motility (Electrical): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 computerized motility system for motility studies, this Sphincter of Oddi Manometric System is used to measure the contraction rates of the Sphincter of Oddi within the gastrointestinal system; for research or diagnostic purposes within a clinical setting. The purpose of conducting these diagnostic motility studies is to determine if a patient's pain is caused by Sphincter of Oddi Dysfunction, where the contractions of the…
Read the full statement (108 words)
When used in conjunction with a computerized motility system for motility studies, this Sphincter of Oddi Manometric System is used to measure the contraction rates of the Sphincter of Oddi within the gastrointestinal system; for research or diagnostic purposes within a clinical setting. The purpose of conducting these diagnostic motility studies is to determine if a patient's pain is caused by Sphincter of Oddi Dysfunction, where the contractions of the Sphincter of Oddi are abnormally high and/or erratic. This dysfunction is most commonly found in patients who have already undergone the removal of their gall bladder. Once diagnosed, the main course of treatment is either medication or sphincterotomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120524 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120524: Sphincter of Oddi Manometric (Som) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120524
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026