MSX · Class II · 21 CFR 870.2300

FDA Product Code MSX: System, Network And Communication, Physiological Monitors

Centralized physiological monitoring networks improve patient safety across hospital units. FDA product code MSX covers network and communication systems for physiological monitoring data.

These systems aggregate and transmit vital sign data from bedside monitors to central nursing stations, electronic health records, and alarm notification systems, enabling surveillance of multiple patients simultaneously and integration of monitoring data into clinical workflows.

MSX devices are Class II medical devices, regulated under 21 CFR 870.2300 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Current Health , Ltd. and Draeger Medical Systems, Inc..

116
Total
116
Cleared
131d
Avg days
1997
Since
Stable submission activity - 6 submissions in the last 2 years
Review times increasing: avg 242d recently vs 125d historically

FDA 510(k) Cleared System, Network And Communication, Physiological Monitors Devices (Product Code MSX)

116 devices
1–24 of 116
Cleared Sep 30, 2025
TigerConnect Alarm Management
K243270
Tigerconnect
Cardiovascular · 349d
Cleared Jul 31, 2025
BeneVision Central Monitoring System
K242728
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular · 324d
Cleared Jun 05, 2025
Central Station
K242750
Nihon Kohden Digital Health Solutions, LLC
Cardiovascular · 266d
Cleared Jan 08, 2025
ANNE View, Central Hub
K242842
Sibel Health, Inc.
Cardiovascular · 111d
Cleared Nov 14, 2024
Hinscope
K241397
Hinlab Sas
Cardiovascular · 182d
Cleared Jul 12, 2024
Infinity Gateway Suite
K233834
Draeger Medical Systems, Inc.
Cardiovascular · 221d
Cleared May 09, 2024
Biofourmis Everion+ (G2)
K233418
Biofourmis Singapore Pte., Ltd.
Cardiovascular · 212d
Cleared Mar 22, 2024
Corsano CardioWatch 287-2 System
K232548
Corsano Health B.V.
Cardiovascular · 212d
Cleared Aug 24, 2023
Current Health System
K231506
Current Health , Ltd.
Cardiovascular · 92d
Cleared Jul 31, 2023
CNS-2101 Central Monitor
K223567
Nihon Kohden Corporation
Cardiovascular · 244d
Cleared Feb 23, 2023
Everion+ System
K213863
Biofourmis Singapore Pte., Ltd.
Cardiovascular · 440d
Cleared Nov 01, 2022
Current Health System
K222550
Current Health , Ltd.
Cardiovascular · 70d
Cleared Jun 07, 2022
Infinity Gateway Suite
K203579
Draeger Medical Systems, Inc.
Cardiovascular · 547d
Cleared Jun 03, 2022
eCareManager 4.5
K211046
Visicu, Inc.
Cardiovascular · 421d
Cleared Jun 01, 2022
BeneVision Central Monitoring System
K220058
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular · 146d
Cleared Feb 11, 2022
Zyter RPM
K212622
Zyter, Inc.
Cardiovascular · 177d
Cleared Dec 09, 2021
AirStrip ONE Web Client with Alarm Communication Management (ACM)
K211949
Airstrip Technologies, Inc.
Cardiovascular · 169d
Cleared Sep 10, 2021
AlertWatch:AC
K210160
Alertwatch, Inc.
Cardiovascular · 232d
Cleared Sep 03, 2021
Current Health Monitoring System Gen 2 (G2)
K210133
Current Health
Cardiovascular · 227d
Cleared Oct 30, 2020
Smart Alarm Interface
K193421
Boxview, LLC
Cardiovascular · 326d
Cleared Oct 30, 2020
Aulisa Multiple Patient Digital Vital Sign Monitoring System
K202497
Taiwan Aulisa Medical Devices Technologies, Inc.
Cardiovascular · 60d
Cleared Jun 05, 2020
Spire Health Remote Patient Monitoring System
K192952
Spire, Inc. D/B/A Spire Health
Cardiovascular · 228d
Cleared May 21, 2020
BeneVision Central Monitoring System
K193391
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular · 167d
Cleared May 11, 2020
Critical Alert CommonPath Enterprise
K193043
Critical Alert
Cardiovascular · 193d

About Product Code MSX - Regulatory Context

510(k) Submission Activity

116 total 510(k) submissions under product code MSX since 1997, with 116 receiving FDA clearance (average review time: 131 days).

Submission volume has remained relatively stable over the observed period, with 6 submissions in the last 24 months.

FDA 510(k) Review Time - MSX Product Code

Recent submissions under MSX have taken an average of 242 days to reach a decision - up from 125 days historically. Manufacturers should account for longer review timelines in current project planning.

MSX devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →