Cleared Traditional

K042309 - BIOSOMNIA-V3

K042309 is an FDA 510(k) clearance for BIOSOMNIA-V3, 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 14-day FDA review.

K042309 · Oxford Biosignals Limited · Neurology device
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Sep 2004
Decision
14d
Days
Class 2
Risk

K042309 is an FDA 510(k) clearance for the BIOSOMNIA-V3. Classified as Reduced- Montage Standard Electroencephalograph (product code OMC), Class II - Special Controls.

Submitted by Oxford Biosignals Limited (Troy, US). The FDA issued a Cleared decision on September 8, 2004 after a review of 14 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K042309

510(k) Number K042309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2004
Decision Date September 08, 2004
Days to Decision 14 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
135d faster than avg
Panel avg: 149d · This submission: 14d
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 27
Devices cleared under the same product code (OMC) and FDA review panel - the closest regulatory comparables to K042309.
ENTERPRISE ELECTROPHYSIOLOGY SYSTEM
K110967 · Neuralynx, Inc. · Jun 2011
NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701
K092477 · Neurowave Systems, Inc. · Oct 2010
NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM
K060523 · Cyberkinetics, Inc. · Mar 2006
ENVOY PATIENT MONITOR
K024245 · Mennen Medical , Ltd. · May 2004
BIOSOMNIA
K021485 · Oxford Biosignals Limited · Sep 2002
OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330
K020335 · Olympic Medical Corp. · Jun 2002
K042309 · BIOSOMNIA-V3
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