Cleared Traditional

K974587 - H2O

K974587 is the FDA 510(k) clearance for H2O by Grass-Telefactor Product Group. It is a Class 2 Neurology device (product code OLV) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K974587 · Grass-Telefactor Product Group · Neurology device
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Mar 1998
Decision
90d
Days
Class 2
Risk

K974587 is an FDA 510(k) clearance for the H2O. Classified as Standard Polysomnograph With Electroencephalograph (product code OLV), Class II - Special Controls.

Submitted by Grass-Telefactor Product Group (West Conshohocken, US). The FDA issued a Cleared decision on March 9, 1998 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Grass-Telefactor Product Group devices

Submission Details

510(k) Number K974587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1997
Decision Date March 09, 1998
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
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 K974587.
XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40
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AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201
K983072 · Nihon Kohden America, Inc. · Dec 1998
MODIFICATION TO BIO-LOGIC SLEEPSCAN
K983913 · Bio-Logic Systems Corp. · Nov 1998
EMBLA
K971813 · Ferguson Medical · Jan 1998
ALICE
K922106 · Healthdyne, Inc. · Jul 1994
ELECTROPHYSIOLOGICAL SYSTEM TO MONITOR SKIN TEMP.
K860458 · Oxford Medilog, Inc. · Aug 1986