# K240798: Cntrl+ Bladder Support Pessary

- Pathway: 510(k) (Traditional)
- Applicant: Cntrl+, Inc.
- Decided: Dec 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: 2 generations back to K930618 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081385: Uresta Pessary, Eastmed, Inc. (2008) Summary page 5.

## Indications for use
The Cntrl+ Bladder Support Pessary is intended for the use in adult women, over 18 years of age who experience involuntary urine loss with physical activity (stress urinary incontinence).

Source page: https://510kreport.com/device/K240798
Methodology: https://510kreport.com/methodology