# K200083: EMBA Hourglass Peripheral Embolization Device (PED)

- Pathway: 510(k) (Special)
- Applicant: Embolic Acceleration, LLC
- Decided: Feb 14, 2020 after 30 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K171845 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171845: EMBA Hourglass Peripheral Embolization Device, Emba Medical Limited (2017) Summary page 4.

## Indications for use
The EMBA Hourglass® Peripheral Embolization Device (PED) is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature in 6-8mm blood vessels. The device is not indicated for use in blood vessels subject to repetitive motion, such as extremity or pulmonary vessels.

Source page: https://510kreport.com/device/K200083
Methodology: https://510kreport.com/methodology