510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192143Substantially Equivalent

Maximus System

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

K192143 is the FDA 510(k) clearance record for Maximus System, a class II device, cleared for Hill-Rom Services Pte, Ltd. on under FDA product code NHJ (Device, Positive Pressure Breathing, Intermittent). FDA records list 5 510(k) clearances for Hill-Rom Services Pte, Ltd., from to . As of , FDA records show 7 recalls naming K192143.

Clearance record

Decision date
Received
(190 days to decision)
Product code
NHJ Device, Positive Pressure Breathing, Intermittent
Regulation
21 CFR 868.5905
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 NHJ

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