# K031169: Motility Visualization System

- Pathway: 510(k) (Traditional)
- Applicant: Sierra Scientific Instruments, Inc.
- Decided: Dec 12, 2003 after 242 days
- Product code: FFX (System, Gastrointestinal Motility (Electrical))
- Device class: 2
- Regulation: 21 CFR 876.1725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011472 (2001). 1 ancestor in all.
15 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011472: Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal Manometry Application, Polygraf ID, Medtronic Functional Diagnostics A/S (2001) Summary page 1.

## Most influential descendants
- K120088: Mcompass Anorectal Manometry System (2012), 7 descendants of its own
- K161785: THD Anopress (2017), 4 descendants of its own
- K180135: THD Anopress with THD SensyProbe (2018), 3 descendants of its own
- K062222: Unitip High Resolution Catheter (2007), 2 descendants of its own
- K143031: mcompass Biofeedback Anorectal Manometry System (2015), 1 descendant of its own

## Recalls of this device
- Oct 12, 2011 · Not classified · Z-0135-2012: The recall was initiated after Given Imaging received a test report during a Canadian licensing process where the AR ManoShield exhibited pinholes and did not pass the test, the Field Safety Correctiv

## Indications for use
The Motility Visualization System obtains a high resolution mapping of pressures within tubular organs of the gastrointestinal tract. These organs include the esophagus from the pharyngeal region to the stomach, the proximal gut (stomach/duodenum), and the anus/rectum. It is used in a medical clinical setting to sense the pressures and store the corresponding data. The system also provides analysis information. The real time data as well as the analysis information can then be viewed by a physician for diagnostic and analysis purposes.

Source page: https://510kreport.com/device/K031169
Methodology: https://510kreport.com/methodology