510(k) · Cleared
ClearedManoScan System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Given Imaging, Ltd. · FFX System, Gastrointestinal Motility (Electrical)
Cleared on Apr 28, 2016 as substantially equivalent to K091070 (Sierra Scientific Instruments, Inc., 2009) and 1 other predicate after a 372-day review. Its family tree reaches back 3 generations to 1982.
- Decided
- Apr 28, 2016
- Review
- 372 days
- Class
- Class II
- Product code
- FFX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K821588 (1982). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK821588 Sandhill DMSSandhill · 1982
- 2 generations backK984444 Insight Gastrointestinal Motility System, Model S980000Sandhill Scientific, Inc. · 1999
- 1 generation backK091070 Manoscan Motility with Impedance Visualization SystemSierra Scientific Instruments, Inc. · 2009
- This deviceK151086 ManoScan SystemGiven Imaging, Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K821588 | Sandhill DMS | Sandhill | 1982 | — |
| −2 | K984444 | Insight Gastrointestinal Motility System, Model S980000 | Sandhill Scientific, Inc. | 1999 | — |
| −1 | K091070 | Manoscan Motility with Impedance Visualization System | Sierra Scientific Instruments, Inc. | 2009 | — |
| 0 (this device) | K151086 | ManoScan System | Given Imaging, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K091070 | Manoscan Motility with Impedance Visualization SystemSummary page 5…Israel III. PREDICATE DEVICE(S) • ManoScan Motility with Impedance Visualization System (K091070) – Primary Predicate • Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal Manometry Application, Poly… | 2009 |
| * | K011472 | Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal Manometry…Summary page 5…e Visualization System (K091070) – Primary Predicate • Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal Manometry Application, Polygraf ID (K011472) – Secondary Predicate IV. DEVICE DESCRIPTION: The ManoScan System provides hardware and software for performing gastrointestina… | 2001 |
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?
- The line of descent spans 34 years and passes through 4 companies; a new generation was cleared every 10.4 years on median.
- 2 of the 8 ancestors have a recall of any class.
How does its category compare?
All FFX devicesFFX System, Gastrointestinal Motility (Electrical): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The ManoScan System provides mapping of pressures and, optionally, impedance within organs of the human gastrointestinal tract. These include the pharynx, upper esophageal sphincter (UES), esophagus, lower esophageal sphincter (LES), stomach, Sphincter of Oddi, small bowel, colon, duodenum and anorectal organs. It is used in a medical clinical setting to acquire pressures and then store the corresponding data for visualization and analysis. The real-time…
Read the full statement (109 words)
The ManoScan System provides mapping of pressures and, optionally, impedance within organs of the human gastrointestinal tract. These include the pharynx, upper esophageal sphincter (UES), esophagus, lower esophageal sphincter (LES), stomach, Sphincter of Oddi, small bowel, colon, duodenum and anorectal organs. It is used in a medical clinical setting to acquire pressures and then store the corresponding data for visualization and analysis. The real-time data as well as the analysis information can be viewed by medically trained personnel for diagnostic and analytic purposes. The ManoScan HRM modules provide high-resolution mapping of the pressure and impedance data. The ManoScan CLT module provides conventional line trace mapping of the pressure data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151086 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151086: ManoScan System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151086
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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