Cleared Traditional

K053248 - SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL

K053248 is an FDA 510(k) clearance for SMARTVEST AIRWAY CLEARANCE SYSTEM, manufactured by Electromed, Inc.. The device is a Class 2 Anesthesiology device with product code BYI cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K053248 · Electromed, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Dec 2005
Decision
10d
Days
Class 2
Risk

K053248 is an FDA 510(k) clearance for the SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL. Classified as Percussor, Powered-electric (product code BYI), Class II - Special Controls.

Submitted by Electromed, Inc. (Mahtomedi, US). The FDA issued a Cleared decision on December 1, 2005 after a review of 10 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 Electromed, Inc. devices

FDA 510(k) Submission Details - K053248

510(k) Number K053248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2005
Decision Date December 01, 2005
Days to Decision 10 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
130d faster than avg
Panel avg: 140d · This submission: 10d
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

Intertek Testing Services
NED 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 - BYI Percussor, Powered-electric

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