Cleared Special

Reflow System Mini and ReFlow Mini Flusher (K223603) - FDA 510(k) Clearance

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

K223603 · Anuncia Medical, Inc. · Neurology device
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Dec 2022
Decision
27d
Days
Class 2
Risk

K223603 is an FDA 510(k) clearance for the Reflow System Mini and ReFlow Mini Flusher. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Anuncia Medical, Inc. (Scottsdale, US). The FDA issued a Cleared decision on December 29, 2022 after a review of 27 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 Anuncia Medical, Inc. devices

Submission Details

510(k) Number K223603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2022
Decision Date December 29, 2022
Days to Decision 27 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
121d faster than avg
Panel avg: 148d · This submission: 27d
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 K223603.
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Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves
K221840 · Integra Lifesciences Production Corporation · Oct 2022
ReFlow System Mini
K221918 · Anuncia Medical, Inc. · Sep 2022