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Rd Set Tfa-1 4016

by Masimo Corporation

Ref 4016

Rd Set Tfa-1 4016 is a device classified as Class IIb in the EU and Class II in the US made by Masimo Corporation, registered in EUDAMED on 15 Jul 2026 (Basic UDI-DI 084399700000Z1T1B01V101F4), cleared under FDA 510(k) K160940 on 23 Nov 2016 and listed in FDA GUDID since 3 Sep 2019 (UDI-DI 10843997010105), active as of 23 Oct 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K160940

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084399700000Z1T1B01V101F4 Basic UDI-DI 10843997010105UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10843997010105 UDI-DI Date3 Sep 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK160940 Date23 Nov 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 084399700000Z1T1B01V101F4 registered 15 Jul 2026 Active
  • FDA 510(k) K160940 decided 23 Nov 2016 Active
  • FDA GUDID UDI-DI 10843997010105 listed 3 Sep 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K160940
  2. Listed FDA GUDID 10843997010105
  3. Registered EUDAMED 084399700000Z1T1B01V101F4

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  • Withdrawn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
Rd Set Tfa-1
Generic name
Pulse oximeter probe, single-use
Device name
RD SET TFA-1 Sensor
Model / reference
4016
Primary DI / UDI-DI
10843997010105
Basic UDI-DI
084399700000Z1T1B01V101F4
Unit of use DI
00843997010108
510(k) Number
FDA product code
DQA
EMDN code
C900301 Pulse oximeter sensors
GMDN term
Pulse oximeter probe, single-use
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 oximeter probe, single-use

Cleared under the same submission (K160940)

Similar devices in this category

Other devices filed under PULSE OXIMETER SENSORS.

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)