# K013597: Tamponade Uterine Balloon Catheter Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ob/Gyn
- Decided: Apr 17, 2002 after 168 days
- Product code: KNA (Instrument, Manual, Specialized Obstetric-Gynecologic)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Mentor U-Stasis Balloon: named in the summary without a submission number
- (no number) Balloon Uterine Stent: named in the summary without a submission number

## Most influential descendants
- K062438: Bakri Postpartum Balloon, Model J-Sos-100500 (2006), 11 descendants of its own
- K170622: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (2017), 6 descendants of its own
- K060289: Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01 (2006), 4 descendants of its own
- K201199: Jada System (2020), 2 descendants of its own
- K091958: Belfort-Dildy Obstetric Tamponade System (2010), 2 descendants of its own

## Indications for use
The Tamponade Uterine Balloon Catheter Set is intended to provide temporary control or reduction of post-partum uterine bleeding when conservative management is warranted. The device is one time use and is supplied sterile.

Source page: https://510kreport.com/device/K013597
Methodology: https://510kreport.com/methodology