Cleared Traditional

K021185 - NERVUS MONITOR

K021185 is an FDA 510(k) clearance for NERVUS MONITOR, manufactured by Taugagreining HF. The device is a Class 2 Neurology device with product code OLV cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K021185 · Taugagreining HF · Neurology device
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Jul 2002
Decision
88d
Days
Class 2
Risk

K021185 is an FDA 510(k) clearance for the NERVUS MONITOR. Classified as Standard Polysomnograph With Electroencephalograph (product code OLV), Class II - Special Controls.

Submitted by Taugagreining HF (Crofton, US). The FDA issued a Cleared decision on July 12, 2002 after a review of 88 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.

FDA 510(k) Submission Details - K021185

510(k) Number K021185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2002
Decision Date July 12, 2002
Days to Decision 88 days
Submission Type Traditional
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
61d faster than avg
Panel avg: 149d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K021185.
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TWIN PLUS
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K013450 · Stellate Systems · Jan 2002
SOMNO STAR & SERIES SLEEP SYSTEM
K012085 · Sensor Medics Corp. · Aug 2001
K021185 · NERVUS MONITOR
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