# K012277: Portex Ring Pessary PVC-Non Sterile; Portex Ring Pessary Polythene- Non Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Sims Portex, Ltd.
- Decided: Feb 11, 2002 after 207 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
Longest line of descent: 1 generation back to K002329 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002329: Pelvx Gellhorn Vaginal Pessary 603-608, Deschutes Medical Products, Inc. (2000) Summary page 1.

## Indications for use
Portex Ring Pessaries provide vaginal support to prevent the uterus from descending. Designed to ease uterine prolapse. Ring Pessaries are also used to correct other uterine displacements and to alleviate stress incontinence by pressure through the anterior vaginal wall onto the urethra.

Source page: https://510kreport.com/device/K012277
Methodology: https://510kreport.com/methodology