LibAirty Airway Clearance System— 510(k) K242063

Name: FDA 510(k) clearance K242063
Creator: U.S. Food and Drug Administration
Published: 2024-12-19

Substantially Equivalent

Synchrony Medical , Ltd.

FDA 510(k) clearance K242063 for LibAirty Airway Clearance System, Substantially Equivalent on 2024-12-19. Applicant: Synchrony Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Synchrony Medical , Ltd.
Product code: Code BYI
Device class: Class 2
Regulation: 21 CFR 868.5665
Advisory panel: Anesthesiology
Date received: 2024-07-15
Decision date: 2024-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Or Yehuda, IL

Download summary PDF View on FDA.gov ↗

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K240959 — Respiratory Muscle Trainer2024-12-18
K233441 — The Vest APX System (PVAPX1)2024-03-22
K222496 — Electromed SmartVest Airway Clearance System2022-11-18

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.