Cleared Traditional

K052381 - GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER

K052381 is an FDA 510(k) clearance for GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIR..., manufactured by Zerusa Limited. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K052381 · Zerusa Limited · Cardiovascular device
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Nov 2005
Decision
83d
Days
Class 2
Risk

K052381 is an FDA 510(k) clearance for the GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Zerusa Limited (Galway, IE). The FDA issued a Cleared decision on November 21, 2005 after a review of 83 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 Zerusa Limited devices

FDA 510(k) Submission Details - K052381

510(k) Number K052381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2005
Decision Date November 21, 2005
Days to Decision 83 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
42d faster than avg
Panel avg: 125d · This submission: 83d
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 93
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K052381.
HEMOSTASIS VALVE
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TERUMO CIRCUIT CONNECTORS
K041697 · Terumo Cardiovascular Systems Corporation · Aug 2004
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K031398 · Guidant Corp. · May 2003
GISH TUBING AND CONNECTORS WITH GBS COATING
K030077 · Gish Biomedical, Inc. · Mar 2003