# K150870: HydroPearl Microspheres, HydroPearl Microspheres

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: Dec 21, 2015 after 264 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- Device class: 2
- Regulation: 21 CFR 870.3300
- 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: 4 generations back to K961923 (1996). 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)
- K021397: Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization, Biosphere Medical, Inc. (2002) Summary page 4.
- K991549: Embosphere Microspheres, Biosphere Medical (2000) Summary page 4.

## Recalls of this device
- Dec 21, 2023 · Class II · Z-0868-2024: Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.

## Indications for use
The HydroPearl Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids.

Source page: https://510kreport.com/device/K150870
Methodology: https://510kreport.com/methodology