# K023906: Pathway CTS2000 Pelvic Floor Training System

- Pathway: 510(k) (Traditional)
- Applicant: The Prometheus Group
- Decided: Feb 19, 2003 after 89 days
- Product code: KPI (Stimulator, Electrical, Non-Implantable, For Incontinence)
- Device class: 2
- Regulation: 21 CFR 876.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K930530 (1995). 4 ancestors in all.
39 later devices descend from it; 3 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001515: Pathway CTS 2000 Pelvic Floor Training System, Model Pathway CTS 2000, The Prometheus Group (2000)
- K974048: Incare Pelvic Floor Therapy System with Desktop Computer, Hollister, Inc. (1997) Summary page 2.

## Most influential descendants
- K050483: Evadri Bladder Control Systems (2005), 37 descendants of its own
- K053434: Myotrac Infiniti Electrical Stimulator (2006), 36 descendants of its own
- K080950: Stiwell MED4 (2009), 34 descendants of its own
- K110179: Incontrol (2012), 21 descendants of its own
- K134020: Intonemv (2014), 10 descendants of its own

## Indications for use
Urinary Incontinence: Stress, Urge and Mixed Incontinence Neuromuscular Reeducation Fecal Incontinence: EMG USE ONLY

Source page: https://510kreport.com/device/K023906
Methodology: https://510kreport.com/methodology