# K960311: Perineometer

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Apr 18, 1996 after 87 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 K891774 (1989). 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)
- K891774: Contimed II Biofeedback Dev Treat of Urin Inconti, Hollister, Inc. (1989) Summary page 2.
- (no number) Perineometer: named in the summary without a submission number

## Most influential descendants
- K993411: Femiscan Clinic System, Model FS-Ictra and Femiscan Personal System, Model FS-HMTR (2000), 0 descendants of its own

## Indications for use
The Contimed Pressure Biofeedback device is intended to provide pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles in the treatment of urinary incontinence.

Source page: https://510kreport.com/device/K960311
Methodology: https://510kreport.com/methodology