# K974036: Pathway Vaginal/Rectal Perineometer Probe

- Pathway: 510(k) (Traditional)
- Applicant: The Prometheus Group
- Decided: Dec 22, 1997 after 59 days
- Product code: HIR (Perineometer)
- Device class: 2
- Regulation: 21 CFR 884.1425
- 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 K911190 (1991). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911190: Perrymeter (TM), Perrymeter Systems (1991) Summary page 2.

## Most influential descendants
- K993976: Pathway Vaginal Emg/Stim Perineometer Sensor, Pathway Anal Emg/Stim Perineometer Sensor (2000), 0 descendants of its own

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

Source page: https://510kreport.com/device/K974036
Methodology: https://510kreport.com/methodology