# K930618: Vaginal Continence Device

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Medical, Inc.
- Decided: May 4, 1995 after 815 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
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K081385: Uresta Pessary (2008), 4 descendants of its own
- K060526: TIPI (2006), 3 descendants of its own
- K131198: Tipi Otc (2013), 2 descendants of its own
- K151413: Always/Tampax bladder supports (2015), 1 descendant of its own
- K083769: Modification to Uresta Pessary (2009), 1 descendant of its own

Source page: https://510kreport.com/device/K930618
Methodology: https://510kreport.com/methodology