# K994079: Reflex Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: Deschutes Medical Products, Inc.
- Decided: Mar 1, 2000 after 90 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 K934552 (1995). 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)
- K934552: Peripump, Deschutes Medical Products, Inc. (1995) Summary page 1.

## Most influential descendants
- K140780: Kegel Smart, Kegelsmart Pearl (2014), 0 descendants of its own

## Indications for use
The ReFlex Treatment System is intended for the treatment of stress incontinence and/or urge incontinence in females.

Source page: https://510kreport.com/device/K994079
Methodology: https://510kreport.com/methodology