# K081385: Uresta Pessary

- Pathway: 510(k) (Traditional)
- Applicant: Eastmed, Inc.
- Decided: Oct 9, 2008 after 146 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 K930618 (1995). 3 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930618: Vaginal Continence Device, Johnson & Johnson Medical, Inc. (1995) Summary page 1.
- K965040: Introl Bladder Neck Support Prosthesis with Removal Tool, Johnson & Johnson Medical, Inc. (1997) Summary page 1.
- K990593: Pelvx Incontinence Dish, Model 301-306, Deschutes Medical Products, Inc. (1999) Summary page 1.
- (no number) Milex Incontinence Ring, Flexible Pessary, Cooper Surgical: named in the summary without a submission number
- (no number) Milex Incontinence Ring with Knob and Support, Cooper Surgical: named in the summary without a submission number

## Most influential descendants
- K083769: Modification to Uresta Pessary (2009), 1 descendant of its own
- K240798: Cntrl+ Bladder Support Pessary (2024), 0 descendants of its own
- K232525: Yoni.Fit Bladder Support (2024), 0 descendants of its own
- K233548: Uresta® (2024), 0 descendants of its own

## Indications for use
This device is 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/K081385
Methodology: https://510kreport.com/methodology