Cleared Traditional

K060919 - ACTICAL

K060919 is an FDA 510(k) clearance for ACTICAL, manufactured by Respironics, Inc.. The device is a Class 2 Neurology device with product code GWK cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K060919 · Respironics, Inc. · Neurology device
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Sep 2006
Decision
171d
Days
Class 2
Risk

K060919 is an FDA 510(k) clearance for the ACTICAL. Classified as Conditioner, Signal, Physiological (product code GWK), Class II - Special Controls.

Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on September 22, 2006 after a review of 171 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1845 - 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 Respironics, Inc. devices

FDA 510(k) Submission Details - K060919

510(k) Number K060919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2006
Decision Date September 22, 2006
Days to Decision 171 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 148d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

GWK Device Classification - Class 2, Special Controls

Product Code GWK Conditioner, Signal, Physiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1845
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 Consultant

Intertek Testing Services
NEIL E DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GWK Conditioner, Signal, Physiological

All 12
Devices cleared under the same product code (GWK) and FDA review panel - the closest regulatory comparables to K060919.
VITALSENSE XHR
K061870 · Respironics, Inc. · Aug 2006
ACTIHEART
K052489 · Respironics, Inc. · Sep 2005
MINI-LOGGER SERIES 2000
K991045 · Mini-Mitter Co., Inc. · Sep 1999
NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300
K905594 · Nihon Kohden America, Inc. · Jun 1991
BIO-LOGIC BANKER
K872290 · Bio-Logic Systems Corp. · Oct 1987
BRAIN FUNCTION MAPPING OPTION FOR PATHF
K843598 · Nicolet Biomedical Instruments · Apr 1985