# K023305: Kegelmaster 2000

- Pathway: 510(k) (Traditional)
- Applicant: Kegelmaster 2000, Ltd.
- Decided: Dec 26, 2002 after 84 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K122800: Inner Peace (2013), 0 descendants of its own

## Indications for use
The Kegelmaster 2000 is intended to assist women in performing Kegel Exercises, which may help control stress urinary incontinence.

Source page: https://510kreport.com/device/K023305
Methodology: https://510kreport.com/methodology