# K181051: IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm

- Pathway: 510(k) (Traditional)
- Applicant: Shape Memory Medical
- Decided: Jun 22, 2018 after 63 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: 17 generations back to K951256 (1995). 99 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113266: Gel-Block Embolization Pledgets, Vascular Solutions, Inc. (2012) Summary page 4.
- K150108: Reverse Medical Micro Vascular Plug System, Reverse Medical Corporation (2015) Summary page 4.
- K043371: Biomerix Vascular Occlusion Device and Loader, Biomerix Corporation (2005) Summary page 4.
- K113658: Amplatzer Vascular Plug 4, Aga Medical Corp. (2012) Summary page 4.

## Most influential descendants
- K182390: IMPEDE-FX Embolization Plug (2019), 0 descendants of its own

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

Source page: https://510kreport.com/device/K181051
Methodology: https://510kreport.com/methodology