# K201199: Jada System

- Pathway: 510(k) (Traditional)
- Applicant: Alydia Health
- Decided: Aug 28, 2020 after 116 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: 3 generations back to K013597 (2002). 3 ancestors in all.
2 later devices descend 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)
- K170622: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component, Cook Incorporated (2017) Summary page 4.

## Most influential descendants
- K212757: Jada System (2021), 1 descendant of its own
- 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/K201199
Methodology: https://510kreport.com/methodology