Cleared Traditional

K141685 - CROC

K141685 is an FDA 510(k) clearance for CROC, manufactured by Combat Medical Systems, LLC. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K141685 · Combat Medical Systems, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K141685

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
Combination Product No
PCCP Authorized No
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.

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 192
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K141685.
Zephyr Vascular Compression Device
K151363 · Advanced Vascular Dynamics · Jul 2015
Bookwalter Gordon Adjustable Compression Element
K143078 · Symmetry Surgical · May 2015
iTClamp50
K150813 · Innovative Trauma Care, Inc. · Apr 2015
RADAR VASCULAR COMPRESSION DEVICE
K142122 · Advanced Vascular Dynamics · Dec 2014
Vasc Band hemostat
K142359 · Lepu Medical Technology (Beijing) Co., Ltd. · Oct 2014
ITCLAMP 50
K140805 · Innovative Trauma Care, Inc. · Oct 2014