Cleared Abbreviated

NOTTA AMBULATORY RECORDER (K013450) - FDA 510(k) Clearance

Class II Neurology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K013450 · Stellate Systems · Neurology device
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Jan 2002
Decision
89d
Days
Class 2
Risk

K013450 is an FDA 510(k) clearance for the NOTTA AMBULATORY RECORDER. 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 January 14, 2002 after a review of 89 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.

View all Stellate Systems devices

Submission Details

510(k) Number K013450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2001
Decision Date January 14, 2002
Days to Decision 89 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 148d · This submission: 89d
Pathway characteristics
Standards-based clearance path.

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.

Regulatory Peers - OLV Standard Polysomnograph With Electroencephalograph

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