# K090286: Pressuremate Manual Femoral Access Compression Device

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Vascular Dynamics
- Decided: Mar 23, 2009 after 46 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 K040615 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053398: Compass Compression Assist Handle, Semler Technologies, Inc. Dba (2006) Summary page 1.
- K040615: Compressar Supercomfort Disc and Strongarm Supercomfort System, Advanced Vascular Dynamics (2004)

## Indications for use
This device is indicated for use to provide hemostasis of the femoral vascular access site during and following catheterization or cannulation procedures.

Source page: https://510kreport.com/device/K090286
Methodology: https://510kreport.com/methodology