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Rd Set 4013

by Masimo Corporation

Ref 4013

Rd Set 4013 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 084399700000Z1T1B01V100F2), cleared under FDA 510(k) K180046 on 23 Oct 2018 and listed in FDA GUDID since 3 Sep 2019 (UDI-DI 10843997009659), active as of 25 Oct 2026. One FDA recall is 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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180046

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084399700000Z1T1B01V100F2 Basic UDI-DI 10843997009659UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10843997009659 UDI-DI Date3 Sep 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK180046 Date23 Oct 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 084399700000Z1T1B01V100F2 registered 15 Jul 2026 Active
  • FDA 510(k) K180046 decided 23 Oct 2018 Active
  • FDA GUDID UDI-DI 10843997009659 listed 3 Sep 2019 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1983-2023 FDA Class II initiated 21 Apr 2023

    TC-I tip clip sensor may produce readings outside the accuracy specification.

Timeline

4 dated events

  1. Cleared FDA 510(k) K180046
  2. Listed FDA GUDID 10843997009659
  3. Recall initiated FDA recalls Z-1983-2023
  4. Registered EUDAMED 084399700000Z1T1B01V100F2

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  • Withdrawn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 Newborn Neonatal EUDAMED
Rd Set GUDID
Generic name
Pulse oximeter probe, single-use
Device name
RD SET Sensors
Model / reference
4013
Description
Newborn Neonatal Pulse Oximeter Adhesive Sensor
Primary DI / UDI-DI
10843997009659
Basic UDI-DI
084399700000Z1T1B01V100F2
Unit of use DI
00843997009652
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 (K180046)

and 8 more cleared under K180046

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)