Electromed SmartVest Airway Clearance System— 510(k) K222496

Name: FDA 510(k) clearance K222496
Creator: U.S. Food and Drug Administration
Published: 2022-11-18

Substantially Equivalent

Electromed, Inc.

FDA 510(k) clearance K222496 for Electromed SmartVest Airway Clearance System, Substantially Equivalent on 2022-11-18. Applicant: Electromed, Inc.. Device class: 2.

Clearance details

Applicant: Electromed, Inc.
Product code: Code BYI
Device class: Class 2
Regulation: 21 CFR 868.5665
Advisory panel: Anesthesiology
Date received: 2022-08-18
Decision date: 2022-11-18
Decision: Substantially Equivalent
Clearance type: Special
Location: New Prague, MN, US

Download summary PDF View on FDA.gov ↗

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K240959 — Respiratory Muscle Trainer2024-12-18
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More clearances from Electromed, Inc.

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K132794 — SMARTVEST AIRWAY CLEARANCE SYSTEM2013-12-19
K053248 — SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL2005-12-01
K040367 — MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ2004-04-07
K982889 — MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 10001999-06-01

Adverse events under product code BYI

product code BYI

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.