Cleared Traditional

K153259 - VasoStat Hemostasis Device

K153259 is an FDA 510(k) clearance for VasoStat Hemostasis Device, manufactured by Forge Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K153259 · Forge Medical, Inc. · Cardiovascular device
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Jan 2016
Decision
57d
Days
Class 2
Risk

K153259 is an FDA 510(k) clearance for the VasoStat Hemostasis Device. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Forge Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on January 6, 2016 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Forge Medical, Inc. devices

FDA 510(k) Submission Details - K153259

510(k) Number K153259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2015
Decision Date January 06, 2016
Days to Decision 57 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXC Clamp, Vascular

All 94
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K153259.
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K112662 · Medtronic Xomed, Inc. · Jan 2012