Cleared Special

K222496 - Electromed SmartVest Airway Clearance System (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K222496 · Electromed, Inc. · Anesthesiology device
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Nov 2022
Decision
92d
Days
Class 2
Risk

K222496 is an FDA 510(k) clearance for the Electromed 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 November 18, 2022 after a review of 92 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

Submission Details

510(k) Number K222496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2022
Decision Date November 18, 2022
Days to Decision 92 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 139d · This submission: 92d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 57
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