Cleared Special

K200807 - IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit (FDA 510(k) Clearance)

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

K200807 · Irras USA, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
33d
Days
Class 2
Risk

K200807 is an FDA 510(k) clearance for the IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Irras USA, Inc. (San Diego, US). The FDA issued a Cleared decision on April 29, 2020 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - the FDA neurology device 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 Irras USA, Inc. devices

Submission Details

510(k) Number K200807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2020
Decision Date April 29, 2020
Days to Decision 33 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 148d · This submission: 33d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JXG Shunt, Central Nervous System And Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
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 Neurology devices follow this clearance model.

Regulatory Peers - JXG Shunt, Central Nervous System And Components

All 257
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