# K982182: Femostop II Plus Disposable Set Model 11166, Femostop II Plus Compression Arch Model 11168, Femostop II Bilateral ADAPT0

- Pathway: 510(k) (Traditional)
- Applicant: Radi Medical Systems AB
- Decided: Sep 18, 1998 after 88 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
No predicates in its family tree.
26 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) FemoStop®II System with FemoStop®II Disposable Set, FemoStop®II Compression Arch, FemoStop®II Bilateral Adapter and FemoStop®II Pump: named in the summary without a submission number

## Most influential descendants
- K983471: Femostop Compression Arch, Femostop Pump, Femostop Bilateral Adapter (1999), 25 descendants of its own
- 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

## Indications for use
The FemoStop®II'S System is indicated in the compression of the femoral artery or vein after catheterization.

Source page: https://510kreport.com/device/K982182
Methodology: https://510kreport.com/methodology