Cleared Traditional

K102048 - ATRAUMATIC VASCULAR CLAMPS

K102048 is an FDA 510(k) clearance for ATRAUMATIC VASCULAR CLAMPS, manufactured by Geomed Medizin-Technik GmbH & Co. KG. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K102048

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.

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 152
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K102048.
RADIAL ARTERY COMPRESSION TOURNIQUET
K111837 · Lepu Medical Technology (Beijing) Co., Ltd. · Sep 2011
WEXLER VASCULAR CLAMP SERIES
K110148 · Microsurgical Laboratories,Inc.Dba Wexler Surgical · Apr 2011
FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH
K110193 · St. Jude Medical Systems AB · Feb 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