Cleared Traditional

K051383 - THE INCOURAGE SYSTEM

K051383 is an FDA 510(k) clearance for THE INCOURAGE SYSTEM, manufactured by Respiratory Technologies, Incorporated. The device is a Class 2 Anesthesiology device with product code BYI cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K051383 · Respiratory Technologies, Incorporated · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
21d
Days
Class 2
Risk

K051383 is an FDA 510(k) clearance for the THE INCOURAGE SYSTEM. Classified as Percussor, Powered-electric (product code BYI), Class II - Special Controls.

Submitted by Respiratory Technologies, Incorporated (Lakeville, US). The FDA issued a Cleared decision on June 17, 2005 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5665 - the FDA anesthesiology and respiratory 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 - K051383

510(k) Number K051383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2005
Decision Date June 17, 2005
Days to Decision 21 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
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
119d faster than avg
Panel avg: 140d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

BYI Device Classification - Class 2, Special Controls

Product Code BYI Percussor, Powered-electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5665
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 Anesthesiology devices follow this clearance model.

Regulatory Consultant

Citech
ROBERT MOSENKIS

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 - BYI Percussor, Powered-electric

All 54
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K051383 · THE INCOURAGE SYSTEM
Download PDF FDA Summary Respiratory Technolog…