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Radius PPG 9954

by Masimo Corporation

Ref 9954

Radius PPG 9954 is a device classified as Class IIb in the EU and Class II in the US made by Masimo Corporation, registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 084399700000Z1T1B06V101GT), cleared under FDA 510(k) K183697 on 15 May 2019 and listed in FDA GUDID since 16 Jul 2020 (UDI-DI 00843997014779), 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

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K183697

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 Number084399700000Z1T1B06V101GT Basic UDI-DI 00843997014779UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00843997014779 UDI-DI Date16 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK183697 Date15 May 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 084399700000Z1T1B06V101GT registered 27 Oct 2026 Active
  • FDA 510(k) K183697 decided 15 May 2019 Active
  • FDA GUDID UDI-DI 00843997014779 listed 16 Jul 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K183697
  2. Listed FDA GUDID 00843997014779
  3. Registered EUDAMED 084399700000Z1T1B06V101GT

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  • Withdrawn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 PPG Kit, M20 EUDAMED
Radius PPG GUDID
Generic name
Pulse Co-oximeter
Model / reference
9954
Primary DI / UDI-DI
00843997014779
Basic UDI-DI
084399700000Z1T1B06V101GT
510(k) Number
FDA product code
DQA
EMDN code
Z1203020408 Pulse oximeters
GMDN term
Pulse Co-oximeter
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
870.2700
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: Pulse Co-oximeter

Cleared under the same submission (K183697)

and 6 more cleared under K183697

Similar devices

Also classified as Pulse Co-oximeter.

Similar devices in this category

Other devices filed under PULSE OXIMETERS.

Other devices from Masimo Corporation

See all devices from Masimo Corporation →

Properties

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