Cleared Traditional

K003127 - REGAIN DESKTOP

K003127 is an FDA 510(k) clearance for REGAIN DESKTOP, manufactured by Srs Medical Systems, Inc.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K003127 · Srs Medical Systems, Inc. · Neurology device
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Jan 2001
Decision
90d
Days
Class 2
Risk

K003127 is an FDA 510(k) clearance for the REGAIN DESKTOP. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Srs Medical Systems, Inc. (Redmond, US). The FDA issued a Cleared decision on January 4, 2001 after a review of 90 days - within the typical 510(k) review window.

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 Srs Medical Systems, Inc. devices

FDA 510(k) Submission Details - K003127

510(k) Number K003127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2000
Decision Date January 04, 2001
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
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 Peers - HCC Device, Biofeedback

All 8
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K003127.
POLYGRAM NET BIOFEEDBACK APPLICATION
K041244 · Medtronic Vascular · Aug 2004
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
J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS
K945826 · Medical Device Inspection Co., Inc. · Aug 1995