Radius VSM
Radius VSM is a modular patient-monitoring platform with an arm-worn touchscreen monitor. The monitor displays measurements received from connected modules and can send them wirelessly to…
Radius VSM is a modular patient-monitoring platform with an arm-worn touchscreen monitor. The monitor displays measurements received from connected modules and can send them wirelessly to systems such as Root or Patient SafetyNet. A rechargeable battery powers the system.
Optional modules provide different measurements. The ECG module connects to disposable skin electrodes for ECG waveforms, heart rate, respiration rate and arrhythmia detection. A separate noninvasive blood-pressure module connects to a cuff for periodic systolic and diastolic readings.
Listed Item
Radius VSM Patient-Worn Vital Signs Monitor, 1/Box
Additional Sensor Functions
The ECG module also incorporates a skin-temperature sensor, accelerometer and gyroscope for temperature and orientation/activity monitoring. The platform can incorporate pulse oximetry and acoustic respiration monitoring. An aggregate respiration feature combines available ECG-, acoustic- and pulse-derived respiration inputs into one displayed value. Available measurements depend on the connected modules and configured technologies.
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
| Shanghai Draeger Medical Instrument Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| General Meditech, Inc. | Shenzhen | Guangdong | Complaint-file establishment | 3 |
Record
| Listed by | Masimo Corporation, United States |
|---|---|
| FDA product code | MHX |
| Device type | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K223498 |
| Record published | 2024-08-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 60 °C; Handling environment temperature 0 to 40 °C; Handling environment humidity 10 to 95 % RH; Storage environment humidity 10 to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9035 | In distribution | |
| 9036 | In distribution | |
| 9037 | In distribution | |
| 9034 | In distribution | |
| 9033 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 326 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 266 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden Corp. | 205 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden America, Inc. | 139 |
| Surveyor Central | Mortara Instrument, Inc. | 71 |
| Tempus Pro | Remote Diagnostic Technologies Ltd. | 44 |
| Surveyor S12 | Mortara Instrument, Inc. | 38 |
| Ultraview | Spacelabs Healthcare (Washington), Inc | 29 |
| Surveyor S19 | Mortara Instrument, Inc. | 26 |
| Vital Signs™ | AirLife Finland Oy | 23 |
| Patient Monitor | Edan Instruments, Inc. | 22 |
| Telemetry Accessories | Philips Medizin Systeme Böblingen GmbH | 21 |
Showing 12 of 589. All products under Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K254209 | 2026-06-04 |
| K250757 | 2025-05-29 |
| K223498 | 2023-06-01 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Masimo Corporation | 510(k) number | 2026-02-20 | Class II | Process control | Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of | 772 |
| Masimo Corporation | 510(k) number | 2026-02-20 | Class II | Process control | Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of | 1,028 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.