# K182390: IMPEDE-FX Embolization Plug

- Pathway: 510(k) (Traditional)
- Applicant: Shape Memory Medical
- Decided: May 23, 2019 after 261 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: 18 generations back to K951256 (1995). 100 ancestors in all.
No later device cites it as a predicate yet.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181051: IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm, Shape Memory Medical (2018) Summary page 4.

## Indications for use
The IMPEDE-FX Embolization Plug is indicated for use with the IMPEDE Embolization Plug to obstruct or reduce the rate of blood flow in the peripheral vasculature.

Source page: https://510kreport.com/device/K182390
Methodology: https://510kreport.com/methodology