Cleared Traditional

K001013 - MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K001013 · Airsep Corp. · Neurology device
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May 2000
Decision
48d
Days
Class 2
Risk

K001013 is an FDA 510(k) clearance for the MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY. Classified as Standard Polysomnograph With Electroencephalograph (product code OLV), Class II - Special Controls.

Submitted by Airsep Corp. (Buffalo, US). The FDA issued a Cleared decision on May 16, 2000 after a review of 48 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 Airsep Corp. devices

Submission Details

510(k) Number K001013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2000
Decision Date May 16, 2000
Days to Decision 48 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
100d faster than avg
Panel avg: 148d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.