# K964663: Favp: Femoral Artery Vascular Pad - Model Number PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F and PAD6EK-FX

- Pathway: 510(k) (Traditional)
- Applicant: Rmds, Inc.
- Decided: Dec 11, 1997 after 385 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.
15 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- 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
- K072890: Stasilon FR (2007), 5 descendants of its own
- K142363: Nustat, Nustat XR (2015), 4 descendants of its own

## Indications for use
The FAVP: Femoral Artery Vascular Pad is used to provide pressure hemostasis following femoral catheterization procedures.

Source page: https://510kreport.com/device/K964663
Methodology: https://510kreport.com/methodology