510(k) · Cleared
ClearedInsight Gastrointestinal Motility System, Model S980000
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 Jan 11, 1999 as substantially equivalent to K961056 (Sandhill Scientific, Inc., 1996) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 1982. 2 later devices descend from it.
- Decided
- Jan 11, 1999
- Review
- 28 days
- Class
- Class II
- Product code
- FFX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K821588 (1982). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK821588 Sandhill DMSSandhill · 1982
- This deviceK984444 Insight Gastrointestinal Motility System, Model S980000Sandhill Scientific, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK091070 Manoscan Motility with Impedance Visualization SystemSierra Scientific Instruments, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK151086 ManoScan SystemGiven Imaging, Ltd. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K821588 | Sandhill DMS | Sandhill | 1982 | — |
| 0 (this device) | K984444 | Insight Gastrointestinal Motility System, Model S980000 | Sandhill Scientific, Inc. | 1999 | — |
| +1 | K091070 | Manoscan Motility with Impedance Visualization System | Sierra Scientific Instruments, Inc. | 2009 | — |
| +2 | K151086 | ManoScan System | Given Imaging, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2016 | 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? (2)
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 |
|---|---|---|---|
| * | K961056 | Bioview Model S960000Summary page 1…afety and performance to those included on prior legally marketed devices manufactured by Sandhill Scientific. The InSIGHT Model S980000 is Substantially Equivalent to: K961056, BioVIEW Model S960000, Manufactured by Sandhill Scientific, Inc. K 821588, Sandhill DMS, Manufactured by Sandhill Scientific, In… | 1996 |
| * | K821588 | Sandhill DMSSummary page 1…manufactured by Sandhill Scientific. The InSIGHT Model S980000 is Substantially Equivalent to: K961056, BioVIEW Model S960000, Manufactured by Sandhill Scientific, Inc. K 821588, Sandhill DMS, Manufactured by Sandhill Scientific, Inc. KasuyYy p-2/3 Device Description and Intended Use The… | 1982 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091070 | Manoscan Motility with Impedance Visualization System | 2009 | 1 |
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.
- Of its descendants, K091070 (Sierra Scientific Instruments, Inc., 2009) has gone furthest, with 1 descendant 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?
The InSIGHT Model S980000 Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons and medically trained personnel as an aid in documenting and diagnosing digestive motility disorders. It may be used for esophageal motility and anorectal motility studies. The system 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/K984444 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984444: Insight Gastrointestinal Motility System, Model S980000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984444
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)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026