# K212757: Jada System

- Pathway: 510(k) (Special)
- Applicant: Alydia Health
- Decided: Sep 30, 2021 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: 4 generations back to K013597 (2002). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201199: Jada System, Alydia Health (2020) Summary page 4.

## Most influential descendants
- K253642: Jada System (Jada-2002) (2026), 0 descendants of its own

## Indications for use
The Jada® System 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/K212757
Methodology: https://510kreport.com/methodology