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LNCS-II rainbow 4059

by Masimo Corporation

Part of a family of 6 devices: see the family page

Ref 4059

LNCS-II rainbow 4059 is a device classified as Class IIb in the EU and Class II in the US made by Masimo Corporation, registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI 084399700000Z1T1B02V000F8), cleared under FDA 510(k) K080238 on 12 May 2008 and listed in FDA GUDID since 7 Oct 2021 (UDI-DI 00843997015554), active as of 22 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) K080238

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084399700000Z1T1B02V000F8 Basic UDI-DI 00843997015554UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00843997015554 UDI-DI Date7 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK080238 Date12 May 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 084399700000Z1T1B02V000F8 registered 30 Sep 2026 Active
  • FDA 510(k) K080238 decided 12 May 2008 Active
  • FDA GUDID UDI-DI 00843997015554 listed 7 Oct 2021 Listed

Recalls

1 recall · FDA

    • Terminated Z-0338-2016 FDA Class II initiated 28 Oct 2015

    These sensors were manufactured with incompatible configurations. This could result in sensors that will provide either no readings or inaccurate readings for the SpCO and SpMet parameters.

Timeline

4 dated events

  1. Cleared FDA 510(k) K080238
  2. Recall initiated FDA recalls Z-0338-2016
  3. Listed FDA GUDID 00843997015554
  4. Registered EUDAMED 084399700000Z1T1B02V000F8

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  • Withdrawn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
LNCS-II rainbow DCI 8λ SpHb, SC-400 EUDAMED
LNCS-II rainbow GUDID
Generic name
Pulse Co-oximeter probe, reusable
Device name
LNCS-II rainbow DCI/DCIP 8λ SpHb
Model / reference
4059
Primary DI / UDI-DI
00843997015554
Basic UDI-DI
084399700000Z1T1B02V000F8
Direct marketing DI
00843997015554
510(k) Number
FDA product code
DQA
EMDN code
C900301 Pulse oximeter sensors
GMDN term
Pulse Co-oximeter probe, reusable
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 Co-oximeter probe, reusable

Cleared under the same submission (K080238)

and 8 more cleared under K080238

Similar devices in this category

Other devices filed under PULSE OXIMETER SENSORS.

Other devices from Masimo Corporation

See all devices from Masimo Corporation →

Properties

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