Cleared Traditional

K002622 - BIOSLEEP

K002622 is an FDA 510(k) clearance for BIOSLEEP, manufactured by Oxford Biosignals Limited. The device is a Class 2 Neurology device with product code OLZ cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K002622 · Oxford Biosignals Limited · Neurology device
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Oct 2000
Decision
61d
Days
Class 2
Risk

K002622 is an FDA 510(k) clearance for the BIOSLEEP. Classified as Automatic Event Detection Software For Polysomnograph With Electroencephalograph (product code OLZ), Class II - Special Controls.

Submitted by Oxford Biosignals Limited (Oxford, Ox4 4 Ga, GB). The FDA issued a Cleared decision on October 23, 2000 after a review of 61 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.

View all Oxford Biosignals Limited devices

FDA 510(k) Submission Details - K002622

510(k) Number K002622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2000
Decision Date October 23, 2000
Days to Decision 61 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
87d faster than avg
Panel avg: 148d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLZ Device Classification - Class 2, Special Controls

Product Code OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Automatically Mark Electroencephalograph And Polysomongraph Signals In Order To Aid In Identification Of Such Events And Annotation Of Prolonged Psg Traces; Automatically Calculate Simple Measures Obtained From Recorded Signals (e.g. Magnitude, Time, Frequency And Simple Statistical Measures Of Marked Events); All Output Subject To Verification By Qualified User
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 - OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph

All 23
Devices cleared under the same product code (OLZ) and FDA review panel - the closest regulatory comparables to K002622.
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