Cleared Traditional

K052489 - ACTIHEART

K052489 is the FDA 510(k) clearance for ACTIHEART by Respironics, Inc.. It is a Class 2 Neurology device (product code GWK) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K052489 · Respironics, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Sep 2005
Decision
15d
Days
Class 2
Risk

K052489 is an FDA 510(k) clearance for the ACTIHEART. 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 27, 2005 after a review of 15 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Respironics, Inc. devices

Submission Details

510(k) Number K052489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2005
Decision Date September 27, 2005
Days to Decision 15 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
133d faster than avg
Panel avg: 148d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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

Devices cleared under the same product code (GWK) and FDA review panel - the closest regulatory comparables to K052489.
ACTICAL
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