Cleared Traditional

K192289 - IRRAflow Catheter

K192289 is the FDA 510(k) clearance for IRRAflow Catheter by Irras USA, Ltd.. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K192289 · Irras USA, Ltd. · Neurology device
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Nov 2019
Decision
84d
Days
Class 2
Risk

K192289 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, Ltd. (San Diego, US). The FDA issued a Cleared decision on November 15, 2019 after a review of 84 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Irras USA, Ltd. devices

Submission Details

510(k) Number K192289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2019
Decision Date November 15, 2019
Days to Decision 84 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 148d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 156
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K192289.
Ventricular Catheter
K200950 · Aesculap, Inc. · May 2020
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
K200807 · Irras USA, Inc. · Apr 2020
M. Blue Adjustable Shunt System
K192266 · Aesculap, Inc. · Nov 2019
MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System
K191684 · Integra LifeSciences Corporation · Oct 2019
Miethke Shunt System GAV 2.0 and SA 2.0 Valves
K190174 · Aesculap, Inc. · Jul 2019
CodMan Certas Plus Programmable Valve
K182265 · Integra Lifesciences Corp. · Nov 2018