# K153591: ebb Complete Tamponade System

- Pathway: 510(k) (Special)
- Applicant: Clinical Innovations, LLC
- Decided: Jan 14, 2016 after 29 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 K972077 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150573: ebb Complete Tamponade System, Clinical Innovations, LLC (2015) Summary page 4.

## Indications for use
The ebb Complete Tamponade System is indicated for use in providing temporary control or reduction of postpartum uterine bleeding. Inflation of the Vaginal Balloon anchors the Uterine Balloon and provides vaginal tamponade if vaginal bleeding is present. The ebb Complete Tamponade System should only be used in the setting of post-partum uterine bleeding when conservative management is warranted.

Source page: https://510kreport.com/device/K153591
Methodology: https://510kreport.com/methodology