# K080206: Modification to Femostop Femoral Compression System

- Pathway: 510(k) (Special)
- Applicant: Radi Medical Systems AB
- Decided: Feb 26, 2008 after 29 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K953781 (1995). 13 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024107: Femostop Femoral Compression System, Radi Medical Systems AB (2002) Summary page 1.
- K062033: BP 101 Digital Blood Pressure Monitor, Kingyield Hongkong Limited (2007) Summary page 1.

## Most influential descendants
- K192413: SiteSeal Femoral Compression Device (2020), 0 descendants of its own
- K120204: Reprocessed Femoral Compression Device (2012), 0 descendants of its own
- K110193: Femostop Plys, Femostop HD, Femostop Compression Arch; Femostop II Plus Set; Femostop II Plus Arch, Bilateral Adapter; F (2011), 0 descendants of its own

## Indications for use
FemoStop® Femoral Compression System is indicated for use in the compression for the femoral artery or vein after vessel cannulation, and in ultrasounded-guided compression repair of a femoral artery pseudoaneurysm

Source page: https://510kreport.com/device/K080206
Methodology: https://510kreport.com/methodology