# K983471: Femostop Compression Arch, Femostop Pump, Femostop Bilateral Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Radi Medical Systems AB
- Decided: Feb 23, 1999 after 144 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: 1 generation back to K954669 (1995). 2 ancestors in all.
25 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954669: Femostop, Femostop Pump, Radi Medical Systems AB (1995) Summary page 1.
- K982182: Femostop II Plus Disposable Set Model 11166, Femostop II Plus Compression Arch Model 11168, Femostop II Bilateral ADAPT0, Radi Medical Systems AB (1998) Summary page 1.

## Most influential descendants
- K024107: Femostop Femoral Compression System (2002), 23 descendants of its own
- K040730: Vascular Solutions D-Stat Clamp Hemostatic Clamp (2004), 17 descendants of its own
- K050146: Vascular Solutions D-Stat Clamp Accessory (2005), 16 descendants of its own
- K053300: Syvekexcel (2006), 14 descendants of its own
- K061219: D-Stat Dry Hemostatic Bandage (2006), 13 descendants of its own

## Indications for use
The FemoStop® system is indicated for use in the compression of the femoral artery or vein after vessel cannulation, and in ultrasound-guided compression repair of a femoral artery pseudoaneurysm.

Source page: https://510kreport.com/device/K983471
Methodology: https://510kreport.com/methodology