# K060526: TIPI

- Pathway: 510(k) (Traditional)
- Applicant: Contipi, Ltd.
- Decided: Jun 9, 2006 after 102 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). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 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.

## Most influential descendants
- K131198: Tipi Otc (2013), 2 descendants of its own
- K151413: Always/Tampax bladder supports (2015), 1 descendant of its own
- K183468: Revive Reusable Bladder Support (2019), 0 descendants of its own

## Indications for use
Vaginal Pessary device is indicated for temporary management of genuine (mild, moderate, and severe) stress urinary incontinence in females. Vaginal Pessary device is designed to be used by any woman, who suffers from stress urinary incontinence.

Source page: https://510kreport.com/device/K060526
Methodology: https://510kreport.com/methodology