510(k) · Cleared
ClearedManoscan Motility with Impedance Visualization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sierra Scientific Instruments, Inc. · FFX System, Gastrointestinal Motility (Electrical)
Cleared on May 19, 2009 as substantially equivalent to K031169 (Sierra Scientific Instruments, Inc., 2003) and 3 other predicates after a 35-day review. Its family tree reaches back 2 generations to 1982. 1 later device descends from it.
- Decided
- May 19, 2009
- Review
- 35 days
- Class
- Class II
- Product code
- FFX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K821588 (1982). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK821588 Sandhill DMSSandhill · 1982
- 1 generation backK984444 Insight Gastrointestinal Motility System, Model S980000Sandhill Scientific, Inc. · 1999
- This deviceK091070 Manoscan Motility with Impedance Visualization SystemSierra Scientific Instruments, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK151086 ManoScan SystemGiven Imaging, Ltd. · 2016
Most influential descendants
Showing 1 of 1 · See all- K151086ManoScan SystemGiven Imaging, Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K821588 | Sandhill DMS | Sandhill | 1982 | — |
| −1 | K984444 | Insight Gastrointestinal Motility System, Model S980000 | Sandhill Scientific, Inc. | 1999 | — |
| 0 (this device) | K091070 | Manoscan Motility with Impedance Visualization System | Sierra Scientific Instruments, Inc. | 2009 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K031169 | Motility Visualization SystemSummary page 1…876.1725 Product Code FFX Establishment registration number: 3005344223 Substantial equivalence claimed to: 1. K031169 - Sierra Scientific Instruments, Inc. -Motility Visualization System; ManoScan 2. K984444 / K012232 - Sandhill Scientific Ins… | 2003 |
| * | K984444 | Insight Gastrointestinal Motility System, Model S980000Summary page 1…number: 3005344223 Substantial equivalence claimed to: 1. K031169 - Sierra Scientific Instruments, Inc. -Motility Visualization System; ManoScan 2. K984444 / K012232 - Sandhill Scientific Instruments, Inc - InSight Motility Visualization System 3. K052338 - Medical Measurement Sys… | 1999 |
| * | K012232 | Insight, Model S980000Summary page 1…3005344223 Substantial equivalence claimed to: 1. K031169 - Sierra Scientific Instruments, Inc. -Motility Visualization System; ManoScan 2. K984444 / K012232 - Sandhill Scientific Instruments, Inc - InSight Motility Visualization System 3. K052338 - Medical Measurement Systems B.V.-… | 2002 |
| * | K052338 | Solar GISummary page 1…Instruments, Inc. -Motility Visualization System; ManoScan 2. K984444 / K012232 - Sandhill Scientific Instruments, Inc - InSight Motility Visualization System 3. K052338 - Medical Measurement Systems B.V.- Solar GI High Resolution Manometry with Impedance System Description: The ManoScan… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151086 | ManoScan System | 2016 | 0 |
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 27 years and passes through 3 companies; a new generation was cleared every 16.6 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K151086 (Given Imaging, Ltd., 2016) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K031169.
How does its category compare?
All FFX devicesFFX System, Gastrointestinal Motility (Electrical): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Motility with Impedance Visualization System obtains a high resolution mapping of pressures and impedance levels 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, impedance levels and video and…
Read the full statement (124 words)
The ManoScan Motility with Impedance Visualization System obtains a high resolution mapping of pressures and impedance levels 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, impedance levels and video and store the corresponding data. The system also provides Visualization and analysis tools and information. The real time data as well as the analysis information can be viewed for diagnostic and analysis purposes with an intention of assisting in the diagnosis and evaluation of gastrointestinal and swallowing disorders. The device is intended for use by gastroenterologists, surgeons and medically trained personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091070 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091070: Manoscan Motility with Impedance Visualization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091070
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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