Cleared Traditional

K141685 - CROC (FDA 510(k) Clearance)

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

K141685 · Combat Medical Systems, LLC · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jan 2015
Decision
217d
Days
Class 2
Risk

K141685 is an FDA 510(k) clearance for the CROC. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Combat Medical Systems, LLC (Alexandria, US). The FDA issued a Cleared decision on January 26, 2015 after a review of 217 days - an extended review 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: 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 Combat Medical Systems, LLC devices

Submission Details

510(k) Number K141685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2014
Decision Date January 26, 2015
Days to Decision 217 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
92d slower than avg
Panel avg: 125d · This submission: 217d
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 201
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