Cleared Special

K190078 - IntraSight (FDA 510(k) Clearance)

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

K190078 · Volcano Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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 104
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K190078.
Baylis Connector Cable
K254114 · Baylis Medical Technologies, Inc. · Jan 2026
IBP cable Becton Dickinson (2606488)
K252827 · Dr?gerwerk AG & Co KGaA · Dec 2025
IBP transducer adapter cable, Argon/BD/Ohmeda, 2m
K251669 · Shanghai Draeger Medical Instrument Co., Ltd. · Sep 2025
SpO2 Extension Cable
K242986 · Beijing Rongrui-Century Science & Technology Co., Ltd. · May 2025
Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC
K243545 · Philips Medizin Systeme B?blingen GmbH · Jan 2025
RT Carbon ECG Leads
K240087 · Ivy Biomedical Systems, Inc. · Sep 2024