Cleared Traditional

K010388 - SONDREX P.A.L. SYSTEM

K010388 is an FDA 510(k) clearance for SONDREX P.A.L. SYSTEM, manufactured by Ohmeda Medical. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 306-day FDA review.

K010388 · Ohmeda Medical · Neurology device
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Dec 2001
Decision
306d
Days
Class 2
Risk

K010388 is an FDA 510(k) clearance for the SONDREX P.A.L. SYSTEM. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Ohmeda Medical (Laurel, US). The FDA issued a Cleared decision on December 11, 2001 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K010388

510(k) Number K010388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2001
Decision Date December 11, 2001
Days to Decision 306 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 149d · This submission: 306d
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 170
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K010388.
ALPHAONE BIOFEEDBACK SYSTEM
K071661 · Telediagnostic Systems, Inc. · Sep 2007
POLYGRAM NET BIOFEEDBACK APPLICATION
K041244 · Medtronic Vascular · Aug 2004
RESPERATE
K020399 · Intercure , Ltd. · Jul 2002
MODEL MES-9000/EMG SYSTEM
K013399 · Myotronics-Noromed, Inc. · Nov 2001
EAR MUFFINS
K012384 · Bio-Logic Systems Corp. · Oct 2001
MODIFICATION TO A620 EEG
K012011 · Stoelting Co. · Oct 2001
K010388 · SONDREX P.A.L. SYSTEM
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