# K153259: VasoStat Hemostasis Device

- Pathway: 510(k) (Traditional)
- Applicant: Forge Medical, Inc.
- Decided: Jan 6, 2016 after 57 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: 5 generations back to K984177 (1998). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123041: Vasostat Hemostasis Device, Forge Medical, Inc. (2013) Summary page 4.
- K142122: Radar Vascular Compression Device, Advanced Vascular Dynamics (2014) Summary page 4.

## Indications for use
The VasoStat™ Hemostasis Device is indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm or lower leg, including radial artery catheterization, pedal or tibial artery catheterization, arterial or venous line removal, hemodialysis, and in patients on anticoagulation therapy.

Source page: https://510kreport.com/device/K153259
Methodology: https://510kreport.com/methodology