# K183468: Revive Reusable Bladder Support

- Pathway: 510(k) (Traditional)
- Applicant: Rinovum Subsidiary 2, LLC
- Decided: Jan 25, 2019 after 42 days
- Product code: HHW (Pessary, Vaginal)
- Device class: 2
- Regulation: 21 CFR 884.3575
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K930618 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151413: Always/Tampax bladder supports, Procter & Gamble (2015) Summary page 4.

## Recalls of this device
- May 2, 2019 · Class II · Z-1952-2019: The product is unable to meet the use life of 31 cycles and may split or crack at the base of the "petals" after repeated use but within the use life of the product (31 uses).

## Indications for use
The Revive bladder support is intended for temporary management of urine leakage caused by stress urinary incontinence (SUI) in women, 18 years and older.

Source page: https://510kreport.com/device/K183468
Methodology: https://510kreport.com/methodology