Cleared Traditional

K222101 - Prism

K222101 is an FDA 510(k) clearance for Prism, manufactured by Graymatters Health , Ltd.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K222101 · Graymatters Health , Ltd. · Neurology device
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Optimized for regulatory review, auditing and printing
Mar 2023
Decision
242d
Days
Class 2
Risk

K222101 is an FDA 510(k) clearance for the Prism. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Graymatters Health , Ltd. (Haifa, IL). The FDA issued a Cleared decision on March 17, 2023 after a review of 242 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Graymatters Health , Ltd. devices

FDA 510(k) Submission Details - K222101

510(k) Number K222101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2022
Decision Date March 17, 2023
Days to Decision 242 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
94d slower than avg
Panel avg: 148d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCC Device Classification - Class 2, Special Controls

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 Consultant

RQM+
Allison Komiyama

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HCC Device, Biofeedback

All 21
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K222101.
A Breathing System (ABS)
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POLYGRAM NET BIOFEEDBACK APPLICATION
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SONDREX P.A.L. SYSTEM
K010388 · Ohmeda Medical · Dec 2001
EAR MUFFINS
K012384 · Bio-Logic Systems Corp. · Oct 2001
EMG RETRAINER
K972487 · Chattanooga Group, Inc. · Sep 1997