Cleared Traditional

K102048 - ATRAUMATIC VASCULAR CLAMPS

K102048 is the FDA 510(k) clearance for ATRAUMATIC VASCULAR CLAMPS by Geomed Medizin-Technik GmbH & Co. KG. It is a Class 2 Cardiovascular device (product code DXC) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K102048 · Geomed Medizin-Technik GmbH & Co. KG · Cardiovascular device
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Nov 2010
Decision
111d
Days
Class 2
Risk

K102048 is an FDA 510(k) clearance for the ATRAUMATIC VASCULAR CLAMPS. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Geomed Medizin-Technik GmbH & Co. KG (Wumlingen, DE). The FDA issued a Cleared decision on November 9, 2010 after a review of 111 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Geomed Medizin-Technik GmbH & Co. KG devices

Submission Details

510(k) Number K102048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2010
Decision Date November 09, 2010
Days to Decision 111 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
14d faster than avg
Panel avg: 125d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 62
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K102048.
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
TR BAND
K070423 · Terumo Medical Corp. · Mar 2007
D-STAT HANDLE, MODEL 8500-053
K063871 · Vascular Solutions, Inc. · Feb 2007
SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING
K062569 · Datascope Corp. · Feb 2007