# K030039: Pathway STM-10 Pelvic Floor Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: The Prometheus Group
- Decided: May 23, 2003 after 137 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: 4 generations back to K930530 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023906: Pathway CTS2000 Pelvic Floor Training System, The Prometheus Group (2003). Cleared while this submission was under review

## Indications for use
Indications For Use * Urinary Incontinence : Stress, Urge and Mixed Incontinence * Neuromuscular Reeducation

Source page: https://510kreport.com/device/K030039
Methodology: https://510kreport.com/methodology