MHXClass II

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

21 CFR 870.1025 / Cardiovascular

MHX is the FDA product code for Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), a class II device type, regulated under 21 CFR 870.1025. As of 2026-09-10, FDA records hold 429 510(k) clearances under this code, the most recent dated 2026-08-28, and 283 recalls.

Classification record

Product code: MHX
Device name: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Regulation: 21 CFR 870.1025
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 430
Ingested recalls: 286

Clearances, product code MHX

By decision year

430 clearances under product code MHX with a decision year between 1987 and 2026, 2003 the highest year at 27.

Show the numbers

510(k) clearances under FDA product code MHX by decision year
Year	Clearances
1987	1
1988	1
1991	4
1992	6
1993	4
1994	2
1995	7
1996	2
1997	2
1998	9
1999	7
2000	21
2001	7
2002	20
2003	27
2004	21
2005	13
2006	26
2007	15
2008	16
2009	13
2010	20
2011	12
2012	16
2013	21
2014	13
2015	14
2016	13
2017	14
2018	11
2019	7
2020	11
2021	5
2022	15
2023	8
2024	5
2025	8
2026	13

Applicants with the most clearances

Product code MHX

Applicants holding the most 510(k) clearances under product code MHX
Applicant	Clearances
GE Healthcare	36
Philips North America LLC	35
GE Medical Systems Information Technologies, Inc.	34
Philips Medizin Systeme Boeblingen GmbH	25
Draeger Medical Systems, Inc.	24
Shenzhen Mindray Bio-Medical Electronics Co.,LTD	23
Edan Instruments, Inc.	17
Philips Medizinsysteme Boeblingen GmbH, Cardiac an	15
GE Healthcare Finland Oy	13
Siemens Medical Solutions USA, Inc.	12

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 110 companies shown, in name order