Cleared Special

IRRAflow Active Fluid Exchange System (AFES) (K222471) - FDA 510(k) Clearance

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

K222471 · Irras USA · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
114d
Days
Class 2
Risk

K222471 is an FDA 510(k) clearance for the IRRAflow Active Fluid Exchange System (AFES). Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Irras USA (San Diego, US). The FDA issued a Cleared decision on December 8, 2022 after a review of 114 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 devices

Submission Details

510(k) Number K222471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2022
Decision Date December 08, 2022
Days to Decision 114 days
Submission Type Special
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
34d faster than avg
Panel avg: 148d · This submission: 114d
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 94
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K222471.
Polaris Valve Electronic Reading Instrument
K222422 · Sophysa · Feb 2023
Certas Plus Programmable Valves
K223330 · Integra Lifesciences Production Corporation · Feb 2023
Reflow System Mini and ReFlow Mini Flusher
K223603 · Anuncia Medical, Inc. · Dec 2022
Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves
K221840 · Integra Lifesciences Production Corporation · Oct 2022
ReFlow System Mini
K221918 · Anuncia Medical, Inc. · Sep 2022
StrataMR II Valves and Shunts
K212641 · Medtronic Neurosurgery · Sep 2021