# K020512: Mti ST#1 Silicone Pessary

- Pathway: 510(k) (Traditional)
- Applicant: Medical Technology and Innovations, Inc.
- Decided: May 16, 2002 after 90 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 K974116 (1998). 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)
- K974116: Pelvx Incontinence Ring, Deschutes Medical Products, Inc. (1998) Summary page 1.
- (no number) Milex Silicone Gehrung Folding Pessary: named in the summary without a submission number

## Indications for use
The MTI ST#1 Silicone Pessary is intended for prescription use to be used in the treatment of genuine stress urinary incontinence. It is not intended to be used while sleeping and thus must be removed on a daily basis before going to bed.

Source page: https://510kreport.com/device/K020512
Methodology: https://510kreport.com/methodology