Cleared Traditional

K122301 - GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE

K122301 is an FDA 510(k) clearance for GUARDIAN II HEMOSTASIS VALVE GUARDIAN I..., manufactured by Vascular Solutions Zerusa , Ltd.. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K122301 · Vascular Solutions Zerusa , Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 2012
Decision
37d
Days
Class 2
Risk

K122301 is an FDA 510(k) clearance for the GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Vascular Solutions Zerusa , Ltd. (Minneapolis, US). The FDA issued a Cleared decision on September 7, 2012 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4290 - 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 Vascular Solutions Zerusa , Ltd. devices

FDA 510(k) Submission Details - K122301

510(k) Number K122301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2012
Decision Date September 07, 2012
Days to Decision 37 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
88d faster than avg
Panel avg: 125d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTL Device Classification - Class 2, Special Controls

Product Code DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4290
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 - DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

All 91
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K122301.
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