# K132313: Pessary

- Pathway: 510(k) (Traditional)
- Applicant: Eis Corporation
- Decided: Dec 5, 2014 after 498 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 K092981 (2010). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092981: Panpac Vaginal Pessary, Panpac Medical Corporation (2010) Summary page 4.

## Most influential descendants
- K190277: ProVate Vaginal Support (2019), 1 descendant of its own
- K253698: Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes (2026), 0 descendants of its own
- K232677: Reia pessary (2024), 0 descendants of its own

## Indications for use
EIS Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women

Source page: https://510kreport.com/device/K132313
Methodology: https://510kreport.com/methodology