Cleared Traditional

K971867 - ALICE 4R SYSTEM

K971867 is an FDA 510(k) clearance for ALICE 4R SYSTEM, manufactured by Healthdyne Technologies, Inc.. The device is a Class 2 Neurology device with product code OLV cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K971867 · Healthdyne Technologies, Inc. · Neurology device
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Aug 1997
Decision
85d
Days
Class 2
Risk

K971867 is an FDA 510(k) clearance for the ALICE 4R SYSTEM. Classified as Standard Polysomnograph With Electroencephalograph (product code OLV), Class II - Special Controls.

Submitted by Healthdyne Technologies, Inc. (Marietta, US). The FDA issued a Cleared decision on August 13, 1997 after a review of 85 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 - K971867

510(k) Number K971867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1997
Decision Date August 13, 1997
Days to Decision 85 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
64d faster than avg
Panel avg: 149d · This submission: 85d
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 63
Devices cleared under the same product code (OLV) and FDA review panel - the closest regulatory comparables to K971867.
DEEGLITE
K974583 · Grass-Telefactor Product Group · Jun 1998
H2O
K974587 · Grass-Telefactor Product Group · Mar 1998
EMBLA
K971813 · Ferguson Medical · Jan 1998
GRASS BRAINWAVE SOFTWARE
K970951 · Astro-Med, Inc. · May 1997
MEDILOG MPA-S
K961638 · Oxford Instruments Medical Systems · Jan 1997
ALICE
K922106 · Healthdyne, Inc. · Jul 1994
K971867 · ALICE 4R SYSTEM
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