Cleared Special

K022121 - PSG INPUT BOX, MODEL JE-912AK (FDA 510(k) Clearance)

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

K022121 · Nihon Kohden America, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
28d
Days
Class 2
Risk

K022121 is an FDA 510(k) clearance for the PSG INPUT BOX, MODEL JE-912AK. Classified as Standard Polysomnograph With Electroencephalograph (product code OLV), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Foothill, US). The FDA issued a Cleared decision on July 29, 2002 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nihon Kohden America, Inc. devices

Submission Details

510(k) Number K022121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2002
Decision Date July 29, 2002
Days to Decision 28 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 148d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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.