Cleared Special

K132794 - SMARTVEST AIRWAY CLEARANCE SYSTEM

K132794 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 Special 510(k) pathway after a 104-day FDA review.

K132794 · Electromed, Inc. · Anesthesiology device
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Dec 2013
Decision
104d
Days
Class 2
Risk

K132794 is an FDA 510(k) clearance for the SMARTVEST AIRWAY CLEARANCE SYSTEM. Classified as Percussor, Powered-electric (product code BYI), Class II - Special Controls.

Submitted by Electromed, Inc. (New Prague, US). The FDA issued a Cleared decision on December 19, 2013 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5665 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Electromed, Inc. devices

FDA 510(k) Submission Details - K132794

510(k) Number K132794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2013
Decision Date December 19, 2013
Days to Decision 104 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 140d · This submission: 104d
Pathway characteristics
Modification to existing cleared device.

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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