# K974117: Pelvx Donut, Pelvx Cube

- Pathway: 510(k) (Traditional)
- Applicant: Deschutes Medical Products, Inc.
- Decided: Apr 27, 1998 after 178 days
- Product code: HHW (Pessary, Vaginal)
- Device class: 2
- Regulation: 21 CFR 884.3575
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K993308: Mentor Evacare Vaginal Pessaries (1999), 2 descendants of its own
- K253698: Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes (2026), 0 descendants of its own
- K250438: CooperSurgical Milex® Pessaries (2025), 0 descendants of its own

## Indications for use
The PelvX Donut Vaginal Pessary is a vaginal pessary intended for support of 3 degree prolapse. The PelvX Cube Vaginal Pessary is a vaginal pessary intended for support of 3" degree prolapse combined with rectocele and/or cystocele.

Source page: https://510kreport.com/device/K974117
Methodology: https://510kreport.com/methodology