# Radius VSM 4889

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/radius-vsm-4889>
- Manufacturer: [Masimo Corporation](https://devicerts.com/manufacturers/masimo-corporation) (United States)
- Device class: Class IIb (EU MDR); Class II (US FDA)
- FDA product code: DXN, MHX
- EMDN: Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS
- GMDN: Wearable multiple vital physiological parameter monitoring system (65834)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 084399700000Y3T5A03V000J9 · UDI-DI 00843997009430 · registered 2026-08-10 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 00843997009430 · listed 2024-08-19 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K223498 · decision 2023-06-01 · decision SESE · status: Active · from GUDID

## Recalls

- Z-2670-2026 · Class II · ongoing · initiated 2026-02-20 · matched through shared submission K223498, may concern other models: 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 true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.
- Z-2671-2026 · Class II · ongoing · initiated 2026-02-20 · matched through shared submission K223498, may concern other models: 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 true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.

## Identity

- Trade name: Radius VSM NIBP Module [EUDAMED]; Radius VSM [FDA GUDID (AccessGUDID)]
- Generic name: Wearable multiple vital physiological parameter monitoring system [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: 4889 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00843997009430 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 084399700000Y3T5A03V000J9 [EUDAMED]
- Direct marketing DI: 00843997009430 [EUDAMED]
- 510(k) Number: K223498 [FDA GUDID (AccessGUDID)]
- FDA product code: DXN [FDA GUDID (AccessGUDID)]
- EMDN code: Z1203020202 [EUDAMED]
- GMDN term: Wearable multiple vital physiological parameter monitoring system (65834) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIb [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 870.1130 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Germany [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Measuring function: Yes [EUDAMED]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Radius VSM 4889, Masimo Corporation. deviCERTS medical device catalogue. https://devicerts.com/devices/radius-vsm-4889 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-24
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/radius-vsm-4889.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/radius-vsm-4889
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.