510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163378Substantially Equivalent

Monarch Airway Clearance System

Hill-Rom Services Pte, Ltd., Singapore, SG / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163378 is the FDA 510(k) clearance record for Monarch Airway Clearance System, a class II device, cleared for Hill-Rom Services Pte, Ltd. on under FDA product code BYI (Percussor, Powered-Electric). FDA records list 5 510(k) clearances for Hill-Rom Services Pte, Ltd., from to . As of , FDA records show one recall naming K163378.

Clearance record

Decision date
Received
(106 days to decision)
Product code
BYI Percussor, Powered-Electric
Regulation
21 CFR 868.5665
Device class
Class II
Review panel
Anesthesiology
Applicant
Hill-Rom Services Pte, Ltd. 1 Yishun Ave. 7, Singapore, SG
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BYI

Trailing 12 months
1 clearance under product code BYI in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BYI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260