# K082701: Uronirs, Model 2000

- Pathway: 510(k) (Traditional)
- Applicant: Urodynamix Technologies, Ltd.
- Decided: Dec 18, 2008 after 93 days
- Product code: FEN (Device, Cystometric, Hydraulic)
- Device class: 2
- Regulation: 21 CFR 876.1620
- 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 K931574 (1993). 2 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073552: Laborie Urodynamic System with Tetra Accessory, Laborie Medical Technologies, Corp. (2008) 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
- K143031: mcompass Biofeedback Anorectal Manometry System (2015), 1 descendant of its own
- K252605: mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) (2025), 0 descendants of its own

## Indications for use
The URONIRS 2000 device is indicated for non-invasive testing of bladder activity in an office or hospital setting.

Source page: https://510kreport.com/device/K082701
Methodology: https://510kreport.com/methodology