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Nellcor DS100A

by Covidien LP

Ref DS100A

Nellcor DS100A 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 B-10884521129474), cleared under FDA 510(k) K012891 on 7 Mar 2002 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10884521129474), active as of 23 Oct 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 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) K012891

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/MDD EUDAMED NumberB-10884521129474 Basic UDI-DI 10884521129474UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521129474 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK012891 Date7 Mar 2002DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10884521129474 registered 9 Oct 2026 Active
  • FDA 510(k) K012891 decided 7 Mar 2002 Active
  • FDA GUDID UDI-DI 10884521129474 listed 24 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0664-05 FDA Unclassified (pre-2012) initiated 18 Oct 2004

    The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.

Timeline

4 dated events

  1. Cleared FDA 510(k) K012891
  2. Recall initiated FDA recalls Z-0664-05
  3. Listed FDA GUDID 10884521129474
  4. Registered EUDAMED B-10884521129474

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Nellcor
Generic name
Transcutaneous blood gas monitor sensor
Device name
DS100A Durasensor Adt Digit X1
Model / reference
DS100A
Primary DI / UDI-DI
10884521129474
Basic UDI-DI
B-10884521129474
510(k) Number
FDA product code
DQA
EMDN code
Z1203020408 Pulse oximeters
GMDN term
Transcutaneous blood gas monitor sensor
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
870.2700
EU registration type
Legacy device (under a directive)
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: Transcutaneous blood gas monitor sensor

Cleared under the same submission (K012891)

and 8 more cleared under K012891

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

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

  • Administering medicine
  • Measuring function
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)