# K230849: Ellavi Ubt

- Pathway: 510(k) (Traditional)
- Applicant: Sinapi Biomedical (Pty), Ltd.
- Decided: Nov 13, 2023 after 230 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.
No later device cites it as a predicate yet.
0 of 4 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 5.

## Indications for use
The ELLAVI UBT device is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

Source page: https://510kreport.com/device/K230849
Methodology: https://510kreport.com/methodology