# K003580: Unitip Gastrointestinal Pressure Sensor Catheter

- Pathway: 510(k) (Abbreviated)
- Applicant: Unisensor AG
- Decided: Jul 31, 2001 after 253 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K062222: Unitip High Resolution Catheter (2007), 2 descendants of its own
- K190208: Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe (2019), 0 descendants of its own
- K102801: Phtip Disposable Isfet Catheter (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K003580
Methodology: https://510kreport.com/methodology