Cleared Special

K162012 - CARESCAPE Central Station V2 (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K162012 · Ge Healthcare · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 2016
Decision
56d
Days
Class 2
Risk

K162012 is an FDA 510(k) clearance for the CARESCAPE Central Station V2. Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by Ge Healthcare (Milwaukee, US). The FDA issued a Cleared decision on September 15, 2016 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2450 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K162012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2016
Decision Date September 15, 2016
Days to Decision 56 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 125d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DXJ Display, Cathode-ray Tube, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2450
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.