MHXFDA Class 2 · 21 CFR 870.1025
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device family · Cardiovascular
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
422
Manufacturers
47
Flagged signals
22
Adverse-event reports
28,238
Code matrix
| FDA product code | MHX |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2015 | 3 | 133.0 | 272 |
| Death | 2019 | 3 | 113.5 | 234 |
| Death | 2019 | 5 | 51.6 | 202 |
| Death | 2010 | 3 | 48.7 | 97 |
| Death | 2011 | 25 | 45.8 | 1,060 |
| Death | 2011 | 31 | 30.3 | 858 |
| Death | 2010 | 21 | 20.6 | 375 |
| Death | 2012 | 5 | 16.7 | 59 |
| Other | 2011 | 3 | 13.1 | 23 |
| Death | 2012 | 4 | 10.3 | 25 |
| Death | 2013 | 3 | 10.0 | 16 |
| Other | 2010 | 6 | 9.2 | 36 |
| Death | 2022 | 46 | 7.7 | 266 |
| Other | 2011 | 4 | 6.1 | 12 |
| Death | 2010 | 8 | 6.0 | 29 |
| Death | 2011 | 7 | 5.2 | 20 |
| Death | 2021 | 29 | 4.9 | 86 |
| Death | 2025 | 7 | 4.5 | 16 |
| Death | 2022 | 7 | 4.5 | 16 |
| Death | 2010 | 4 | 3.9 | 6 |
| Death | 2014 | 11 | 2.2 | 6 |
| Death | 2021 | 11 | 2.2 | 6 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 28,238 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Philips Medizin Systeme Boeblingen GmbH | 25 | 2026 | — |
| DRAEGER MEDICAL SYSTEMS, INC. | 24 | 2024 | — |
| Philips Medical Systems | 24 | 2019 | — |
| Ge Medical Systems Information Technologies | 24 | 2010 | — |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 21 | 2026 | — |
| Edan Instruments, Inc. | 16 | 2025 | — |
| GE Healthcare Finland Oy | 13 | 2023 | — |
| Siemens Medical Solutions USA, Inc. | 12 | 2003 | — |
| NIHON KOHDEN AMERICA, INC. | 11 | 2008 | — |
| Datex-Ohmeda | 11 | 2005 | — |
| GE Healthcare | 10 | 2020 | — |
| FUKUDA DENSHI USA, INC. | 8 | 2015 | — |
| GE Medical Systems Information Technologies, Inc. | 8 | 2025 | — |
| Philips Medical Systems, Inc. | 8 | 2004 | — |
| MORTARA INSTRUMENT, INC. | 7 | 2018 | — |
| Guangdong Biolight Meditech Co., Ltd. | 5 | 2017 | — |
| GE Medical Systems China Co., Ltd. | 5 | 2015 | — |
| Hewlett-Packard Co. | 5 | 1994 | — |
| AGILENT TECHNOLOGIES, INC. | 5 | 2001 | — |
| Philips Medizin Systeme Böblingen GmbH | 5 | 2025 | — |
| Datex-Ohmeda, Inc. | 4 | 2003 | — |
| Schiller AG | 4 | 2023 | — |
| Datascope Corp. | 4 | 2007 | — |
| NIHON KOHDEN CORPORATION | 3 | 2021 | — |
| Alivecor, Inc. | 2 | 2026 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
Vista CMS · Shanghai Draeger Medical Instrument Co., Ltd.510(k) · 2026-04-24
uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors · Shenzhen Mindray Bio-Medical Electronics Co., Ltd.510(k) · 2026-04-16
Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427) · Shanghai Draeger Medical Instrument Co., Ltd.510(k) · 2026-04-10
IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) · Philips Medizin Systeme Boeblingen GmbH510(k) · 2026-02-06
Corvair Monza · AliveCor, Inc.510(k) · 2026-01-09
Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro) · Shenzhen Comen Medical Instruments Co.,Ltd510(k) · 2025-12-17
IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) · Philips Medizin Systeme Böblingen GmbH510(k) · 2025-11-10
IntelliVue Patient monitors MX400, MX450, MX500, MX550 · Philips Medizin Systeme Boeblingen GmbH510(k) · 2025-10-17
IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) · Philips Medizin Systeme Böblingen GmbH510(k) · 2025-09-02
Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) · Edan Instruments, Inc.510(k) · 2025-07-29
Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P · Ge Medical Systems Information Technologies, Inc.510(k) · 2025-07-09
Radius VSM and Accessories · Masimo Corporation510(k) · 2025-05-29
Telemetry Monitor 5500 Release 4.0 (867232) · Philips Medizin Systeme Böblingen GmbH510(k) · 2025-05-05
Infinity CentralStation Wide · Draeger Medical Systems, Inc.510(k) · 2024-08-01
Patient Monitor (RespArray) · Edan Instruments, Inc.510(k) · 2024-06-28
Corvair · AliveCor, Inc.510(k) · 2024-06-07
Patient Monitor (iX10, iX12, iX15) · Edan Instruments, Inc.510(k) · 2024-04-19
Central Monitoring System (MFM-CMS) · Edan Instruments, Inc.510(k) · 2024-02-05
IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468) · Philips Medizin Systeme Boeblingen GmbH510(k) · 2023-12-19
IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) · Philips Medizin Systeme Boeblingen GmbH510(k) · 2023-11-22
Infinity CentralStation Wide, Infinity M300, Infinity M300+ · Draeger Medical Systems, Inc.510(k) · 2023-10-17
IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066) · Philips Medizin Systeme Boeblingen GmbH510(k) · 2023-08-22
ARGUS PB-3000 · Schiller AG510(k) · 2023-07-06
Radius VSM and Accessories · Masimo Corporation510(k) · 2023-06-01
CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) · GE Healthcare Finland Oy510(k) · 2023-04-06
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.