# K011472: Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal Manometry Application, Polygraf ID

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Functional Diagnostics A/S
- Decided: Aug 10, 2001 after 88 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
No predicates in its family tree.
16 later devices descend from it; 2 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K031169: Motility Visualization System (2003), 15 descendants of its own
- 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

Source page: https://510kreport.com/device/K011472
Methodology: https://510kreport.com/methodology