# K981277: Periform

- Pathway: 510(k) (Traditional)
- Applicant: Verimed Holdings, Inc.
- Decided: Nov 20, 1998 after 226 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). 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)
- K913912: Verimed Perineometer, Verimed Holdings, Inc. (1992) Summary page 2.
- K911190: Perrymeter (TM), Perrymeter Systems (1991) Summary page 2.

## Indications for use
Biofeedback/monitoring vaginal probe intended for: Treatment of stress, urge, and mixed incontinence. Facilitation in identification of the pubococcygeus muscles. Strengthening of the pelvic floor muscles through biofeedback-assisted pelvic floor exercises.

Source page: https://510kreport.com/device/K981277
Methodology: https://510kreport.com/methodology