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Nellcor DEC8

by Covidien LP

Ref DEC8

Nellcor DEC8 is a device classified as Class I in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 29 Sep 2026 (Basic UDI-DI 0763000B00025648F), cleared under FDA 510(k) K012891 on 7 Mar 2002 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10884522042987), 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) K012891

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 Number0763000B00025648F Basic UDI-DI 10884522042987UDI-DIDate29 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884522042987 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 0763000B00025648F registered 29 Sep 2026 Active
  • FDA 510(k) K012891 decided 7 Mar 2002 Active
  • FDA GUDID UDI-DI 10884522042987 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 10884522042987
  4. Registered EUDAMED 0763000B00025648F

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  • Withdrawn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
Electrical-only medical device connection cable, reusable
Device name
Nellcor NS Snsr Acc for Reus/Dis. Snsrs
Model / reference
DEC8
Primary DI / UDI-DI
10884522042987
Basic UDI-DI
0763000B00025648F
510(k) Number
FDA product code
DQA
EMDN code
Z1203020408 Pulse oximeters
GMDN term
Electrical-only medical device connection cable, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.2700
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 8 Feet

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Electrical mains power extension cable

Cleared under the same submission (K012891)

and 8 more cleared under K012891

Similar devices in this category

Other devices filed under PULSE OXIMETERS.

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See all devices from Covidien LP →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)