# K091070: Manoscan Motility with Impedance Visualization System

- Pathway: 510(k) (Traditional)
- Applicant: Sierra Scientific Instruments, Inc.
- Decided: May 19, 2009 after 35 days
- Product code: FFX (System, Gastrointestinal Motility (Electrical))
- Device class: 2
- Regulation: 21 CFR 876.1725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K821588 (1982). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031169: Motility Visualization System, Sierra Scientific Instruments, Inc. (2003) Summary page 1.
- K984444: Insight Gastrointestinal Motility System, Model S980000, Sandhill Scientific, Inc. (1999) Summary page 1.
- K012232: Insight, Model S980000, Sandhill Scientific, Inc. (2002) Summary page 1.
- K052338: Solar GI, Medical Measurement Systems B.V. (2005) Summary page 1.

## Most influential descendants
- K151086: ManoScan System (2016), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K091070
Methodology: https://510kreport.com/methodology