Monarch Airway Clearance System— 510(k) K163378

Clearance details

Applicant

Hill-Rom Services Pte, Ltd.

Product code

Code BYI

Device class

Class 2

Regulation

21 CFR 868.5665

Advisory panel

Anesthesiology

Date received

2016-12-01

Decision date

2017-03-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Singapore, SG

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• K151689 — MetaNeb 4 System2016-03-17
• K124032 — METANEB2013-04-25

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 →

• Z-0192-2018 — Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on the label is Hill-Rom Services Pte. Ltd., Singapore. The Monarch Airway Clearance System, Model 1000, is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physicians choice of treatment. It is indicated for patients having difficulty with secretion clearance or the presence of atelectasis caused by mucus plugging.Class II·Terminated·HILL-ROM MANUFACTURING, INC.·20170915

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163378.