# K062438: Bakri Postpartum Balloon, Model J-Sos-100500

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ob/Gyn
- Decided: Oct 27, 2006 after 67 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
Longest line of descent: 1 generation back to K013597 (2002). 1 ancestor in all.
11 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013597: Tamponade Uterine Balloon Catheter Set, Cook Ob/Gyn (2002) Summary page 1.

## Most influential descendants
- K170622: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (2017), 6 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
- K212757: Jada System (2021), 1 descendant of its own
- K150573: ebb Complete Tamponade System (2015), 1 descendant of its own

## Indications for use
The Bakri Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

Source page: https://510kreport.com/device/K062438
Methodology: https://510kreport.com/methodology