# K232525: Yoni.Fit Bladder Support

- Pathway: 510(k) (Traditional)
- Applicant: Watkins-Conti Products, Inc.
- Decided: May 17, 2024 after 270 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: 3 generations back to K930618 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083769: Modification to Uresta Pessary, Eastmed, Inc. (2009) Summary page 5.

## Indications for use
The Yōni.Fit® Bladder Support is intended for the temporary management of urine leakage caused by stress urinary incontinence (SUI) in women, 18 years and older.

Source page: https://510kreport.com/device/K232525
Methodology: https://510kreport.com/methodology