Cleared Special

K190078 - IntraSight

K190078 is the FDA 510(k) clearance for IntraSight by Volcano Corporation. It is a Class 2 Cardiovascular device (product code DSA) cleared through the Special 510(k) pathway after a 26-day FDA review.

K190078 · Volcano Corporation · Cardiovascular device
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Feb 2019
Decision
26d
Days
Class 2
Risk

K190078 is an FDA 510(k) clearance for the IntraSight. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Volcano Corporation (San Diego, US). The FDA issued a Cleared decision on February 11, 2019 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2900 - 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.

View all Volcano Corporation devices

Submission Details

510(k) Number K190078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2019
Decision Date February 11, 2019
Days to Decision 26 days
Submission Type Special
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
99d faster than avg
Panel avg: 125d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DSA Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2900
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 - DSA Cable, Transducer And Electrode, Patient, (including Connector)

All 47
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K190078.
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ECG Cable
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Multi-Link X2 ECG and SpO2 Adapter
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Patient Cables and Leadwires , Disposable ECG Leadwires
K182327 · Orantech, Inc. · Jan 2019
Curbell branded Patient Monitoring Cables
K182220 · Curbell Medical Products, Inc. · Nov 2018
Medline Patient Cables and Lead Wires
K181726 · Medline Industries, Inc. · Sep 2018