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Nellcor 901-A

by Covidien LP

Part of a family of 18 devices: see the family page

Ref 901-A

Nellcor 901-A is a device classified as Class IIb in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 13 Aug 2026 (Basic UDI-DI 0763000B00008778R), cleared under FDA 510(k) K993637 on 24 Nov 1999 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10884521084070), active as of 24 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) K993637

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00008778R Basic UDI-DI 10884521084070UDI-DIDate13 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521084070 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK993637 Date24 Nov 1999DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00008778R registered 13 Aug 2026 Active
  • FDA 510(k) K993637 decided 24 Nov 1999 Active
  • FDA GUDID UDI-DI 10884521084070 listed 24 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0665-05 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) K993637
  2. Recall initiated FDA recalls Z-0665-05
  3. Listed FDA GUDID 10884521084070
  4. Registered EUDAMED 0763000B00008778R

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  • Withdrawn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
OxySoft Neonatal-Adult SpO2 sensor
Model / reference
901-A
Primary DI / UDI-DI
10884521084070
Basic UDI-DI
0763000B00008778R
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: Transcutaneous blood gas monitor sensor

Cleared under the same submission (K993637)

Similar devices in this category

Other devices filed under PULSE OXIMETERS.

Other devices from Covidien LP

  • LigaSure MRASILF19

    Class II

  • Shiley 110860

    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

  • Supplied sterile
  • Single use
  • Measuring function
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)