# K024107: Femostop Femoral Compression System

- Pathway: 510(k) (Special)
- Applicant: Radi Medical Systems AB
- Decided: Dec 24, 2002 after 11 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: 3 generations back to K953781 (1995). 10 ancestors in all.
23 later devices descend from it; 5 cite it directly.
0 of 34 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)
- 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.
- K983471: Femostop Compression Arch, Femostop Pump, Femostop Bilateral Adapter, Radi Medical Systems AB (1999) Summary page 1.
- K010933: Seal-on Topical Hempstatic Powder Spray, Alltracel Pharma, Ltd. (2002)
- K920796: Deroyal Transparent Film Dressign, Deroyal Industries, Inc. (1992) Summary page 1.
- K962425: Bonopty Coaxial Bone Biopsy System with Eccentric Drill (10-1072,3,4), Radi Medical Systems AB (1996) Summary page 1.

## Most influential descendants
- 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
- K090620: Quikclot Inteventional, Model P/N 182 (2009), 5 descendants of its own

## Indications for use
FemoStopB 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/K024107
Methodology: https://510kreport.com/methodology