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Radius VSM 4695

by Masimo Corporation

Ref 4695

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084399700000Z6T5A03V000MX Basic UDI-DI 10843997016015UDI-DIDate10 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10843997016015 UDI-DI Date23 Feb 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK223498 Date1 Jun 2023DecidedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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.

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  • Withdrawn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 - ECG Electrode Adult 3-Lead EUDAMED
Radius VSM GUDID
Generic name
Electrocardiographic electrode, single-use
Model / reference
4695
Primary DI / UDI-DI
10843997016015
Basic UDI-DI
084399700000Z6T5A03V000MX
Unit of use DI
00843997016018
510(k) Number
FDA product code
DPS
EMDN code
Z1203020285 Multi-parameter monitors - consumables
GMDN term
Electrocardiographic electrode, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
870.2340
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

Related devices

Cleared under the same submission (K223498)

Show all (11)

Other devices from Masimo Corporation

See all devices from Masimo Corporation →

Properties

  • Single use
  • Measuring function
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (20)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No