Cleared Traditional

K053248 - SMARTVEST AIRWAY CLEARANCE SYSTEM

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
Download Printable Device Report (PDF)
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
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 Peers - BYI Percussor, Powered-electric

All 18
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