Cleared Traditional

ATRAUMATIC VASCULAR CLAMPS (K102048) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

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