# K012574: Reprocessed Femoral Compression Device

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Jul 18, 2002 after 343 days
- Product code: NMF (Clamp, Vascular, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K915280 (1992). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915280: Femostop, Radi Medical Systems AB (1992) Summary page 6.

## Most influential descendants
- K120204: Reprocessed Femoral Compression Device (2012), 0 descendants of its own

## Recalls of this device
- Aug 8, 2008 · Not classified · Z-0557-2009: SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of th

## 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/K012574
Methodology: https://510kreport.com/methodology