# K073552: Laborie Urodynamic System with Tetra Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Laborie Medical Technologies, Corp.
- Decided: Mar 5, 2008 after 78 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: 1 generation back to K931574 (1993). 1 ancestor in all.
10 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931574: Advance Model Uds-Adv, Laborie Medical Technologies, Ltd. (1993) Summary page 3.

## Most influential descendants
- K082701: Uronirs, Model 2000 (2008), 8 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
- K143031: mcompass Biofeedback Anorectal Manometry System (2015), 1 descendant of its own

## Indications for use
Laborie Urodynamic systems are intended for Urodynamic testing. The traditional equipment performs standard test including uroflometry, cystometry, micturition, electromyography and urethral pressure profiles. The accessory to our standard equipment, Tetra near infrared spectroscopy, uses non-invasive testing of bladder activity, aiding in the diagnosis of patients with lower urinary tract symptoms, that is patients who suffer from urinary incontinence All Urodynamic equipment including the Laborie Urodynamic system with Tetra Accessory are for use under the direction of a licensed physician or health care professional in an office or hospital setting.

Source page: https://510kreport.com/device/K073552
Methodology: https://510kreport.com/methodology