# K250276: Nitinol Enhanced Device (NED)

- Pathway: 510(k) (Traditional)
- Applicant: Embolization, Inc.
- Decided: May 15, 2025 after 104 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 K060078 (2006). 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)
- K132578: Interlock - 18 Fibered Idc Occlusion System, Boston Scientific Corp (2013) Summary page 6.

## Indications for use
The Nitinol Enhanced Device (NED) is intended for arterial and venous embolization in the peripheral vasculature. This device is not intended for neurovascular use.

Source page: https://510kreport.com/device/K250276
Methodology: https://510kreport.com/methodology