Cleared Traditional

K021485 - BIOSOMNIA

K021485 is an FDA 510(k) clearance for BIOSOMNIA, manufactured by Oxford Biosignals Limited. The device is a Class 2 Neurology device with product code OMC cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K021485 · Oxford Biosignals Limited · Neurology device
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Sep 2002
Decision
126d
Days
Class 2
Risk

K021485 is an FDA 510(k) clearance for the BIOSOMNIA. Classified as Reduced- Montage Standard Electroencephalograph (product code OMC), Class II - Special Controls.

Submitted by Oxford Biosignals Limited (Crofton, US). The FDA issued a Cleared decision on September 11, 2002 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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 Oxford Biosignals Limited devices

FDA 510(k) Submission Details - K021485

510(k) Number K021485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2002
Decision Date September 11, 2002
Days to Decision 126 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
22d faster than avg
Panel avg: 148d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OMC Device Classification - Class 2, Special Controls

Product Code OMC Reduced- Montage Standard Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A User-specified And/or Sponsor-specified Locations With A Reduced Array (i.e. Less Than < 16) Of Electrodes
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 - OMC Reduced- Montage Standard Electroencephalograph

All 18
Devices cleared under the same product code (OMC) and FDA review panel - the closest regulatory comparables to K021485.
Ceribell Pocket EEG Device
K170363 · Ceribell, Inc. · May 2017
ENTERPRISE ELECTROPHYSIOLOGY SYSTEM
K110967 · Neuralynx, Inc. · Jun 2011
ENVOY PATIENT MONITOR
K024245 · Mennen Medical , Ltd. · May 2004
OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330
K020335 · Olympic Medical Corp. · Jun 2002
CRYSTAL-EEG MODEL 10 (MODEL 10)
K970672 · Cleveland Medical Devices, Inc. · May 1997
ACCESSORY TO ECG ANALYSIS SYS.
K781130 · Oxford Medilog, Inc. · Aug 1978