# K993976: Pathway Vaginal Emg/Stim Perineometer Sensor, Pathway Anal Emg/Stim Perineometer Sensor

- Pathway: 510(k) (Traditional)
- Applicant: The Prometheus Group
- Decided: Feb 22, 2000 after 90 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: 2 generations back to K911190 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974036: Pathway Vaginal/Rectal Perineometer Probe, The Prometheus Group (1997) Summary page 2.
- K891773: Microgyn II Elec Stim Device Treat of Urin Inconti, Hollister, Inc. (1989) Summary page 2.
- K930530: Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc, Hollister, Inc. (1995) Summary page 2.

## Indications for use
* Urinary Incontinence : Stress, Urge and Mixed Incontinence * Neuromuscular Reeducation * Fecal Incontinence (EMG Use only)

Source page: https://510kreport.com/device/K993976
Methodology: https://510kreport.com/methodology