MHX · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Cardiovascular · 21 CFR 870.1025 · Class 2
Overview
| Product Code | MHX |
|---|---|
| Device Name | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Regulation | 21 CFR 870.1025 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.
Classification Rationale
Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
Recent Cleared Devices (20 of 425)
Showing 20 most recent of 425 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254209 | Radius VSM and Accessories | Masimo Corporation | Jun 4, 2026 | SESE |
| K252840 | M12 Telemetry System | Global Instrumentation, LLC | May 29, 2026 | SESE |
| K260098 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | May 20, 2026 | SESE |
| K250349 | Vista CMS | Shanghai Draeger Medical Instrument Co., Ltd. | Apr 24, 2026 | SESE |
| K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Apr 16, 2026 | SESE |
| K252250 | 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. | Apr 10, 2026 | SESE |
| K252726 | IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) | Philips Medizin Systeme Boeblingen GmbH | Feb 6, 2026 | SESE |
| K252589 | Corvair Monza | AliveCor, Inc. | Jan 9, 2026 | SESE |
| K250854 | 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.,Ltd | Dec 17, 2025 | SESE |
| K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) | Philips Medizin Systeme Böblingen GmbH | Nov 10, 2025 | SESE |
| K251146 | IntelliVue Patient monitors MX400, MX450, MX500, MX550 | Philips Medizin Systeme Boeblingen GmbH | Oct 17, 2025 | SESE |
| K250453 | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) | Philips Medizin Systeme Böblingen GmbH | Sep 2, 2025 | SESE |
| K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) | Edan Instruments, Inc. | Jul 29, 2025 | SESE |
| K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | Ge Medical Systems Information Technologies, Inc. | Jul 9, 2025 | SESE |
| K250757 | Radius VSM and Accessories | Masimo Corporation | May 29, 2025 | SESE |
| K242962 | Telemetry Monitor 5500 Release 4.0 (867232) | Philips Medizin Systeme Böblingen GmbH | May 5, 2025 | SESE |
| K240312 | Infinity CentralStation Wide | Draeger Medical Systems, Inc. | Aug 1, 2024 | SESE |
| K240320 | Patient Monitor (RespArray) | Edan Instruments, Inc. | Jun 28, 2024 | SESE |
| K231010 | Corvair | AliveCor, Inc. | Jun 7, 2024 | SESE |
| K232962 | Patient Monitor (iX10, iX12, iX15) | Edan Instruments, Inc. | Apr 19, 2024 | SESE |
Top Applicants
- Philips Medizin Systeme Boeblingen GmbH — 25 clearances
- Draeger Medical Systems, Inc. — 24 clearances
- Ge Medical Systems Information Technologies — 24 clearances
- Philips Medical Systems — 24 clearances
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — 22 clearances
