# K050470: Concentric Embolic Pearls

- Pathway: 510(k) (Traditional)
- Applicant: Concentric Medical, Inc.
- Decided: May 6, 2005 after 72 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 K961923 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991549: Embosphere Microspheres, Biosphere Medical (2000) Summary page 1.
- K010026: Embogold Microsphere, Biosphere Medical, Inc. (2001) Summary page 1.
- K951314: Truefill Pva Particles, Cordis Neurovascular, Inc. (1995) Summary page 1.
- K965174: Trufill Pva Particles, Cordis Neurovascular, Inc. (1997) Summary page 1.

## Indications for use
The Concentric Embolic Pearls are indicated for use in the embolization of hypervascularized tumors in the peripheral vasculature.

Source page: https://510kreport.com/device/K050470
Methodology: https://510kreport.com/methodology