# K150958: LifePearl Microshperes

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: Sep 17, 2015 after 161 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: 5 generations back to K010026 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083091: LC Bead Microspheres, Bead Block Compressible Microspheres, Biocompatibles UK Limited (2008) Summary page 4.

## Recalls of this device
- May 29, 2025 · Class II · Z-2188-2025: Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted embolization), add

## Indications for use
LIFEPEARL™ Microspheres are indicated for embolization of hypervascular tumors and arteriovenous malformations (AVM’s).

Source page: https://510kreport.com/device/K150958
Methodology: https://510kreport.com/methodology