510(k) · Cleared
Recalled · Class III · 2023Insight, 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 Jun 7, 2002 after a 326-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 15 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 7, 2002
- Review
- 326 days
- Class
- Class II
- Product code
- FFX
- Recalls
- 2
- Predicates
- 0
15 later devices descend from it, 3 citing it directly.
- This deviceK012232 Insight, Model S980000Sandhill Scientific, Inc. · 2002
- Descendant · cites it directly · 9 of its ownK092850 EndoflipCrospon, Ltd. · 2009
- Descendant · 2 generations on · 7 of its ownK120997 Barostat Software OptionCrospon, Ltd. · 2012
- Descendant · 2 generations on · 4 of its ownK160725 EndoFLIPCrospon, Ltd. · 2016
- Descendant · 3 generations on · 2 of its ownK183072 EndoFLIP SystemCrospon, Ltd. · 2019 · Recalled
- Descendant · cites it directly · 2 of its ownK142327 smARTrack Feeding Tube SystemArt Healthcare, Ltd. · 2015
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K092850EndoflipCrospon, Ltd. · 2009 · cites it directly9descendants
- K120997Barostat Software OptionCrospon, Ltd. · 2012 · 2 generations on7descendants
- K160725EndoFLIPCrospon, Ltd. · 2016 · 2 generations on4descendants
- K183072EndoFLIP SystemCrospon, Ltd. · 2019 · 3 generations on2descendants
- K142327smARTrack Feeding Tube SystemArt Healthcare, Ltd. · 2015 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012232 | Insight, Model S980000 | Sandhill Scientific, Inc. | 2002 | — |
| +1 | K092850 | Endoflip | Crospon, Ltd. | 2009 | — |
| +2 | K120997 | Barostat Software Option | Crospon, Ltd. | 2012 | — |
| +2 | K160725 | EndoFLIP | Crospon, Ltd. | 2016 | — |
| +3 | K183072 | EndoFLIP System | Crospon, Ltd. | 2019 | 1 |
| +1 | K142327 | smARTrack Feeding Tube System | Art Healthcare, Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (15)
See all 153 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 |
|---|---|---|---|---|
| Jul 25, 2023 | Class III | Z-2521-2023 | Labeling Change Control | GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0. |
| Feb 23, 2009 | Not classified | Z-1487-2012 | Software change control | Software error may produce incorrect esophageal contraction readings. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K092850 (Crospon, Ltd., 2009) has gone furthest, with 9 descendants 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 1nSiglit Model S9SOOOO Gastrointestinal Motility System is intended for use by gastroenterologists, surgcons, and medically trained personnel as an aid in documenting and diagnosing digestive motility disorders. Tt may be used for esophageal, biliary>and anorectal motility studies. The system includes analysis software, but rcquircs skilled interpretation by a physician tu make a diagnosis. The Accessory Model MTT, when used in conjunction with a pH…
Read the full statement (128 words)
The 1nSiglit Model S9SOOOO Gastrointestinal Motility System is intended for use by gastroenterologists, surgcons, and medically trained personnel as an aid in documenting and diagnosing digestive motility disorders. Tt may be used for esophageal, biliary>and anorectal motility studies. The system includes analysis software, but rcquircs skilled interpretation by a physician tu make a diagnosis.
The Accessory Model MTT, when used in conjunction with a pH probe, can be used as an aid in dif'fertsntiating acid vs. non-acid reflux evcnts. In addition, the Accessory Model MTT is intended to measure motor knction of the proximal gastrointestinal tract including swallow effeGtiveness and directional bolus transport. by means of intraiurninal impedance recording,
The Accessory Model h4II component of the TnSight Gastrointestinal Motility System is not intended for use in biliary studies.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K012232 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012232: Insight, 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/K012232
Report an extraction error
Are you the manufacturer?
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