# K150573: ebb Complete Tamponade System

- Pathway: 510(k) (Special)
- Applicant: Clinical Innovations, LLC
- Decided: Mar 25, 2015 after 19 days
- Product code: OQY (Intrauterine Tamponade Balloon)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K972077 (1997). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091958: Belfort-Dildy Obstetric Tamponade System, Glenveigh Surgical, LLC (2010) Summary page 4.

## Most influential descendants
- K153591: ebb Complete Tamponade System (2016), 0 descendants of its own

## Recalls of this device
- Jan 5, 2015 · Class II · Z-0123-2016: Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect the ability to deli

## 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/K150573
Methodology: https://510kreport.com/methodology