# K120204: Reprocessed Femoral Compression Device

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Apr 3, 2012 after 71 days
- Product code: NMF (Clamp, Vascular, Reprocessed)
- 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: 5 generations back to K953781 (1995). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012574: Reprocessed Femoral Compression Device, Sterilmed, Inc. (2002)
- K080206: Modification to Femostop Femoral Compression System, Radi Medical Systems AB (2008) Summary page 1.

## Indications for use
The Reprocessed Femoral Compression Device is intended for use in the compression of the femoral artery or vein after catheterization.

Source page: https://510kreport.com/device/K120204
Methodology: https://510kreport.com/methodology