510(k) · Cleared
ClearedInsight Sphincter of Oddi Manometry Module, Model S981300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sandhill Scientific, Inc. · FFX System, Gastrointestinal Motility (Electrical)
Cleared on May 12, 1999 as substantially equivalent to K932306 (Sandhill Scientific, Inc., 1994) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- May 12, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- FFX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K900058 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK900058 Wilson-Cook Biliary Motility CatheterWilson-Cook Medical, Inc. · 1990
- This deviceK990441 Insight Sphincter of Oddi Manometry Module, Model S981300Sandhill Scientific, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900058 | Wilson-Cook Biliary Motility Catheter | Wilson-Cook Medical, Inc. | 1990 | — |
| 0 (this device) | K990441 | Insight Sphincter of Oddi Manometry Module, Model S981300 | Sandhill Scientific, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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? (3)
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 |
|---|---|---|---|
| * | K932306 | MicroinfusorSummary page 2…ng device with features equivalent in safety and performance to those included on prior legally marketed devices. The InSIGHT SOM Module is Substantially Equivalent to: K932306 Microinfuser, Manufactured by Sandhill Scientific, Inc. K900058, Wilson-Cook Biliary Motility Catheter, Manufactured by Wilson-C… | 1994 |
| * | K900058 | Wilson-Cook Biliary Motility CatheterSummary page 2…hose included on prior legally marketed devices. The InSIGHT SOM Module is Substantially Equivalent to: K932306 Microinfuser, Manufactured by Sandhill Scientific, Inc. K900058, Wilson-Cook Biliary Motility Catheter, Manufactured by Wilson-Cook Medical, Inc. Pre-Amendment, Hewlett-Packard Model 7788-A, M… | 1990 |
| * | — | Hewlett-Packard Model 7788-A 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.
What does this lineage say?
- None of the 2 ancestors has a 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?
The Sphincter of Oddi Manometry Module is intended for use by Gastroenterologists or Surgeons to determine intraluminal pressures within the pancreaticobiliary ductal system and motor activity within the sphincter of Oddi zone. The InSIGHT Sphincter of Oddi Manometry Module includes analysis software, but requires skilled interpretation by a physician to make a diagnosis.
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/K990441 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990441: Insight Sphincter of Oddi Manometry Module, Model S981300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990441
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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