Cleared Special

K150235 - CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels (FDA 510(k) Clearance)

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

K150235 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
79d
Days
Class 2
Risk

K150235 is an FDA 510(k) clearance for the CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLE.... Classified as Amplifier And Signal Conditioner, Transducer Signal (product code DRQ), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Lowell, US). The FDA issued a Cleared decision on April 22, 2015 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2060 - 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 K150235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2015
Decision Date April 22, 2015
Days to Decision 79 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
46d faster than avg
Panel avg: 125d · This submission: 79d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DRQ Amplifier And Signal Conditioner, Transducer Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2060
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.