Cleared Traditional

K173603 - Monarch Airway Clearance System (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173603 · Hill-Rom Holdings, Inc. · Anesthesiology device
Oct 2018
Decision
337d
Days
Class 2
Risk

K173603 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 Holdings, Inc. (Singapore, SG). The FDA issued a Cleared decision on October 24, 2018 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

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

Submission Details

510(k) Number K173603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2017
Decision Date October 24, 2018
Days to Decision 337 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 225d · This submission: 337d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.