# K253642: Jada System (Jada-2002)

- Pathway: 510(k) (Traditional)
- Applicant: Organon, LLC
- Decided: May 15, 2026 after 177 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: 5 generations back to K013597 (2002). 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)
- K212757: Jada System, Alydia Health (2021) Summary page 5.

## Indications for use
The Jada System (Jada-2002) is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.

Source page: https://510kreport.com/device/K253642
Methodology: https://510kreport.com/methodology