Cleared Traditional

K021807 - GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM

K021807 is the FDA 510(k) clearance for GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM by Grass Instrument Co.. It is a Class 2 Neurology device (product code OLV) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K021807 · Grass Instrument Co. · Neurology device
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Optimized for regulatory review, auditing and printing
Aug 2002
Decision
87d
Days
Class 2
Risk

K021807 is an FDA 510(k) clearance for the GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM. Classified as Standard Polysomnograph With Electroencephalograph (product code OLV), Class II - Special Controls.

Submitted by Grass Instrument Co. (Braintree, US). The FDA issued a Cleared decision on August 29, 2002 after a review of 87 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 Grass Instrument Co. devices

Submission Details

510(k) Number K021807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2002
Decision Date August 29, 2002
Days to Decision 87 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 148d · This submission: 87d
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.

Regulatory Peers - OLV Standard Polysomnograph With Electroencephalograph

All 27
Devices cleared under the same product code (OLV) and FDA review panel - the closest regulatory comparables to K021807.
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XLTEK SLEEP SYSTEM
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PSG INPUT BOX, MODEL JE-912AK
K022121 · Nihon Kohden America, Inc. · Jul 2002
NEUROFAX, MODELS EEG-1100A, EEG-9100A
K011204 · Nihon Kohden America, Inc. · May 2001
BIO-LOGIC SLEEPSCAN NETLINK
K003681 · Bio-Logic Systems Corp. · Dec 2000