# K231554: UniPearls® Embolic Microspheres

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Haowei Medical Technology Co., Ltd.
- Decided: Nov 14, 2023 after 168 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: 2 generations back to K153102 (2015). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172372: QuadraSphere Microspheres, Biosphere Medical, S.A. (2017) Summary page 5.

## Most influential descendants
- K252812: UniPearls® Embolic Microspheres (2026), 0 descendants of its own

## Indications for use
UniPearls® Embolic Microspheres are indicated for embolization of hypervascularized tumors including hepatoma, and peripheral arteriovenous malformations.

Source page: https://510kreport.com/device/K231554
Methodology: https://510kreport.com/methodology