# K001515: Pathway CTS 2000 Pelvic Floor Training System, Model Pathway CTS 2000

- Pathway: 510(k) (Traditional)
- Applicant: The Prometheus Group
- Decided: Jul 31, 2000 after 76 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
No predicates in its family tree.
50 later devices descend from it; 4 cite it directly.
0 of 51 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
- K023906: Pathway CTS2000 Pelvic Floor Training System (2003), 39 descendants of its own
- 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

Source page: https://510kreport.com/device/K001515
Methodology: https://510kreport.com/methodology