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)
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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.

View all Respiratory Technologies, Incorporated devices

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
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 Peers - BYI Percussor, Powered-electric

All 26
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