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Nellcor RS10

by Covidien LP

Ref RS10

Nellcor RS10 is a device classified as Class IIb in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 9 Oct 2026 (Basic UDI-DI 0763000B00025628B), cleared under FDA 510(k) K904039 on 27 Dec 1990 and listed in FDA GUDID since 27 May 2017 (UDI-DI 10884522042529), 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

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K904039

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 Number0763000B00025628B Basic UDI-DI 10884522042529UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884522042529 UDI-DI Date27 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK904039 Date27 Dec 1990DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00025628B registered 9 Oct 2026 Active
  • FDA 510(k) K904039 decided 27 Dec 1990 Active
  • FDA GUDID UDI-DI 10884522042529 listed 27 May 2017 Listed

Recalls

1 recall · FDA

    • Terminated Z-1125-2017 FDA Class II initiated 16 Dec 2016

    Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.

Timeline

4 dated events

  1. Cleared FDA 510(k) K904039
  2. Recall initiated FDA recalls Z-1125-2017
  3. Listed FDA GUDID 10884522042529
  4. Registered EUDAMED 0763000B00025628B

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  • Withdrawn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
Nellcor
Generic name
Pulse oximeter probe, single-use
Device name
Nellcor NS Disposable Sensors
Model / reference
RS10
Primary DI / UDI-DI
10884522042529
Basic UDI-DI
0763000B00025628B
510(k) Number
FDA product code
DQA
EMDN code
Z1203020408 Pulse oximeters
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
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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 (K904039)

Similar devices in this category

Other devices filed under PULSE OXIMETERS.

Other devices from Covidien LP

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    Class II

  • Shiley 110860

    Class II

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    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

  • Single use
  • Measuring function
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)