# K970145: Perineometer & Vaginal Probe (Biofeedback Monitor #20 and Vaginal Probe)

- Pathway: 510(k) (Traditional)
- Applicant: Biosearch Medical Products, Inc.
- Decided: Aug 11, 1997 after 208 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 K902843 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902843: Biosearch Anal Biofeedback Device, Biosearch Medical Products, Inc. (1990) Summary page 3.
- K913736: Dobbhoff Anorect Biofeed Syst Five Div Fecal Const, Biosearch Medical Products, Inc. (1992) Summary page 5.

## Indications for use
The Perineometer (Biofeedback monitor) and vaginal probe are intended to be used to assist the patient in exercising her pelvic muscles (referred to Kegal exercises) which may lead to increased bladder control.

Source page: https://510kreport.com/device/K970145
Methodology: https://510kreport.com/methodology