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Radius VSM 9036

by Masimo Corporation

Ref 9036

Radius VSM 9036 is a device classified as Class IIb in the EU and Class II in the US made by Masimo Corporation, registered in EUDAMED on 10 Aug 2026 (Basic UDI-DI 084399700000Z0T2A03V000EQ), cleared under FDA 510(k) K223498 on 1 Jun 2023 and listed in FDA GUDID since 19 Aug 2024 (UDI-DI 00843997011549), active as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223498

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084399700000Z0T2A03V000EQ Basic UDI-DI 00843997011549UDI-DIDate10 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00843997011549 UDI-DI Date19 Aug 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK223498 Date1 Jun 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 084399700000Z0T2A03V000EQ registered 10 Aug 2026 Active
  • FDA 510(k) K223498 decided 1 Jun 2023 Active
  • FDA GUDID UDI-DI 00843997011549 listed 19 Aug 2024 Listed

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2670-2026 FDA Class II initiated 20 Feb 2026
    • Ongoing Z-2671-2026 FDA Class II initiated 20 Feb 2026

    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.

Timeline

5 dated events

  1. Cleared FDA 510(k) K223498
  2. Listed FDA GUDID 00843997011549
  3. Recall initiated FDA recalls Z-2670-2026
  4. Recall initiated FDA recalls Z-2671-2026
  5. Registered EUDAMED 084399700000Z0T2A03V000EQ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Radius VSM with Reusable Pod & NIBP EUDAMED
Radius VSM GUDID
Generic name
Wearable multiple vital physiological parameter monitoring system
Model / reference
9036
Primary DI / UDI-DI
00843997011549
Basic UDI-DI
084399700000Z0T2A03V000EQ
510(k) Number
FDA product code
MHX
EMDN code
Z1203020202 Transportable/portable multi–parameter patient monitors
GMDN term
Wearable multiple vital physiological parameter monitoring system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
870.1025
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Wearable multiple vital physiological parameter monitoring system

Cleared under the same submission (K223498)

and 7 more cleared under K223498

Similar devices in this category

Other devices filed under TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS.

Other devices from Masimo Corporation

See all devices from Masimo Corporation →

Properties

  • Measuring function
  • Prescription use
  • Convenience kit
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)