Cleared Abbreviated

K010728 - HARMONE-SCHWARZER EEG SYSTEM

K010728 is an FDA 510(k) clearance for HARMONE-SCHWARZER EEG SYSTEM, manufactured by Stellate Systems. The device is a Class 2 Neurology device with product code OLV cleared through the Abbreviated 510(k) pathway after a 70-day FDA review.

K010728 · Stellate Systems · Neurology device
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May 2001
Decision
70d
Days
Class 2
Risk

K010728 is an FDA 510(k) clearance for the HARMONE-SCHWARZER EEG SYSTEM. Classified as Standard Polysomnograph With Electroencephalograph (product code OLV), Class II - Special Controls.

Submitted by Stellate Systems (Westmount, Quebec, CA). The FDA issued a Cleared decision on May 21, 2001 after a review of 70 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K010728

510(k) Number K010728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2001
Decision Date May 21, 2001
Days to Decision 70 days
Submission Type Abbreviated
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
79d faster than avg
Panel avg: 149d · This submission: 70d
Pathway characteristics
Standards-based clearance path.

OLV Device Classification - Class 2, Special Controls

Product Code OLV Standard Polysomnograph With Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain And Other Signals (such As Electromyography, Respiratory And/or Oximetry Signals) For Sleep Recordings. May Also Be Used To Allow On-screen Review, User-controlled Annotation And User-controlled Marking Of Data.
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 - OLV Standard Polysomnograph With Electroencephalograph

All 64
Devices cleared under the same product code (OLV) and FDA review panel - the closest regulatory comparables to K010728.
TWIN PLUS
K012976 · Grass-Telefactor Divison · Feb 2002
NOTTA AMBULATORY RECORDER
K013450 · Stellate Systems · Jan 2002
SOMNO STAR & SERIES SLEEP SYSTEM
K012085 · Sensor Medics Corp. · Aug 2001
LIFELINES TRACKIT
K010460 · Lifelines , Ltd. · May 2001
NEUROFAX, MODELS EEG-1100A, EEG-9100A
K011204 · Nihon Kohden America, Inc. · May 2001
COMPUMEDICS SIESTA SYSTEM
K003175 · Compumedics Limited · Dec 2000
K010728 · HARMONE-SCHWARZER EEG SYSTEM
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