# K252812: UniPearls® Embolic Microspheres

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Haowei Medical Technology Co., Ltd.
- Decided: Jul 31, 2026 after 330 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: 3 generations back to K153102 (2015). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231554: UniPearls® Embolic Microspheres, Suzhou Haowei Medical Technology Co., Ltd. (2023) Summary page 5.

## 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/K252812
Methodology: https://510kreport.com/methodology