# K192684: HydroPearl Microspheres

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: Jan 22, 2020 after 118 days
- Product code: NOY (Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia)
- Device class: 2
- Regulation: 21 CFR 876.5550
- 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: 1 generation back to DEN160040 (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)
- DEN160040: Embosphere Microspheres, Biosphere Medical, S.A. (2017) 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 the embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH).

Source page: https://510kreport.com/device/K192684
Methodology: https://510kreport.com/methodology