Cleared Traditional

K163378 - Monarch Airway Clearance System

K163378 is an FDA 510(k) clearance for Monarch Airway Clearance System, manufactured by Hill-Rom Services Pte, Ltd.. The device is a Class 2 Anesthesiology device with product code BYI cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K163378 · Hill-Rom Services Pte, Ltd. · Anesthesiology device
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Mar 2017
Decision
106d
Days
Class 2
Risk

K163378 is an FDA 510(k) clearance for the Monarch Airway Clearance System. Classified as Percussor, Powered-electric (product code BYI), Class II - Special Controls.

Submitted by Hill-Rom Services Pte, Ltd. (Singapore, SG). The FDA issued a Cleared decision on March 17, 2017 after a review of 106 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hill-Rom Services Pte, Ltd. devices

FDA 510(k) Submission Details - K163378

510(k) Number K163378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2016
Decision Date March 17, 2017
Days to Decision 106 days
Submission Type Traditional
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
34d faster than avg
Panel avg: 140d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 37
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