# K170622: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Mar 31, 2017 after 30 days
- Product code: OQY (Intrauterine Tamponade Balloon)
- 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: 2 generations back to K013597 (2002). 2 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062438: Bakri Postpartum Balloon, Model J-Sos-100500, Cook Ob/Gyn (2006) Summary page 5.

## Most influential descendants
- K201199: Jada System (2020), 2 descendants of its own
- K212757: Jada System (2021), 1 descendant of its own
- K253642: Jada System (Jada-2002) (2026), 0 descendants of its own
- K230849: Ellavi Ubt (2023), 0 descendants of its own
- K223098: Bakri Essential Postpartum Balloon (2022), 0 descendants of its own

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

Source page: https://510kreport.com/device/K170622
Methodology: https://510kreport.com/methodology