Cleared Traditional

K092544 - INSTRUMED VASCULAR CLAMPS

K092544 is an FDA 510(k) clearance for INSTRUMED VASCULAR CLAMPS, manufactured by Instrumed International, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K092544 · Instrumed International, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 2009
Decision
68d
Days
Class 2
Risk

K092544 is an FDA 510(k) clearance for the INSTRUMED VASCULAR CLAMPS. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Instrumed International, Inc. (Schaumburg, US). The FDA issued a Cleared decision on October 26, 2009 after a review of 68 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 Instrumed International, Inc. devices

FDA 510(k) Submission Details - K092544

510(k) Number K092544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2009
Decision Date October 26, 2009
Days to Decision 68 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
57d faster than avg
Panel avg: 125d · This submission: 68d
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 104
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K092544.
MICROFRANCE(R) WORMALD VASCULAR CLAMP
K112662 · Medtronic Xomed, Inc. · Jan 2012
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
K113182 · Edwards Lifesciences, LLC · Dec 2011
EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER
K112694 · Edwards Lifesciences, LLC · Oct 2011
MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM
K080206 · Radi Medical Systems AB · Feb 2008
TR BAND
K070423 · Terumo Medical Corp. · Mar 2007
D-STAT HANDLE, MODEL 8500-053
K063871 · Vascular Solutions, Inc. · Feb 2007