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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Ohmeda Medical devices

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
158d slower than avg
Panel avg: 148d · 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 53
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K010388.
EEGER4 MODEL 4.3
K122879 · Eeg Software, LLC · Feb 2013
EMG SYSTEM
K111687 · Myotronics-Noromed, Inc. · Sep 2011
POLYGRAM NET BIOFEEDBACK APPLICATION
K041244 · Medtronic Vascular · Aug 2004
EAR MUFFINS
K012384 · Bio-Logic Systems Corp. · Oct 2001
NEUROCOMP
K993654 · Neurocybernetics · Jan 2000
NORODYN 8000 SEMG SYSTEM, ND-8000
K992439 · Myotronics-Noromed, Inc. · Aug 1999