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Radius VSM 4828

by Masimo Corporation

Ref 4828

Radius VSM 4828 is a device classified as Class IIb in the EU and Class II in the US made by Masimo Corporation, registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI 084399700000Z2T1B05V101HD), cleared under FDA 510(k) K223498 on 1 Jun 2023 and listed in FDA GUDID since 19 Aug 2024 (UDI-DI 10843997006184), active as of 7 Nov 2026.

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

Recall on shared 510(k) K223498; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223498

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084399700000Z2T1B05V101HD Basic UDI-DI 10843997006184UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10843997006184 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 084399700000Z2T1B05V101HD registered 30 Sep 2026 Active
  • FDA 510(k) K223498 decided 1 Jun 2023 Active
  • FDA GUDID UDI-DI 10843997006184 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 on shared 510(k) K223498
    • Ongoing Z-2671-2026 FDA Class II initiated 20 Feb 2026 on shared 510(k) K223498

    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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

5 dated events

  1. Cleared FDA 510(k) K223498
  2. Listed FDA GUDID 10843997006184
  3. Recall initiated FDA recalls Z-2670-2026
  4. Recall initiated FDA recalls Z-2671-2026
  5. Registered EUDAMED 084399700000Z2T1B05V101HD

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 RAS-45 Acoustic Respiration Sensor, Adult EUDAMED
Radius VSM GUDID
Generic name
Electronic acoustic stethoscope
Device name
Acoustic Disposable Sensors
Model / reference
4828
Primary DI / UDI-DI
10843997006184
Basic UDI-DI
084399700000Z2T1B05V101HD
Unit of use DI
00843997006187
510(k) Number
FDA product code
BZQ
EMDN code
Z12030285 Vital signs monitoring instruments - consumables
GMDN term
Electronic acoustic stethoscope
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
868.2375
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: Electronic acoustic stethoscope

Cleared under the same submission (K223498)

and 7 more cleared under K223498

Similar devices in this category

Other devices filed under VITAL SIGNS MONITORING INSTRUMENTS.

Other devices from Masimo Corporation

See all devices from Masimo Corporation →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)