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uSpO2 3849

by Masimo Corporation

Ref 3849

uSpO2 3849 is a device classified as Class IIb in the EU and Class II in the US made by Masimo Corporation, registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI 084399700000Z1T0A11V000E6), cleared under FDA 510(k) K182887 on 22 Mar 2019 (1 earlier submission) and listed in FDA GUDID since 4 Sep 2020 (UDI-DI 00843997008853), 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) K182887

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084399700000Z1T0A11V000E6 Basic UDI-DI 00843997008853UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00843997008853 UDI-DI Date4 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK182887 Date22 Mar 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 084399700000Z1T0A11V000E6 registered 23 Sep 2026 Active
  • FDA 510(k) K182887 decided 22 Mar 2019 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00843997008853 listed 4 Sep 2020 Listed

Recalls

1 recall · FDA

    • Terminated Z-0213-2015 FDA Class II initiated 30 Sep 2014

    Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance when these wires are crossed is that when a low SpO2 value is measured, a high SpO2 value would be displayed on the monitoring device. Additionally when a high SpO2 value is measured, a low SpO2 value would be displayed on the monitoring device.

Timeline

5 dated events

  1. Cleared FDA 510(k) K121914
  2. Recall initiated FDA recalls Z-0213-2015
  3. Cleared FDA 510(k) K182887
  4. Listed FDA GUDID 00843997008853
  5. Registered EUDAMED 084399700000Z1T0A11V000E6

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
uSpO2 Masimo SET Oximetry Cable, ODU EUDAMED
uSpO2 GUDID
Generic name
Rigid optical ureteroscope
Model / Ref / Catalog
3849
Primary DI / UDI-DI
00843997008853
Basic UDI-DI
084399700000Z1T0A11V000E6
Direct marketing DI
00843997008853
510(k) Number
FDA product code
DQA
EMDN code
Z1203020408 Pulse oximeters
GMDN term
Rigid optical ureteroscope
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: Rigid optical ureteroscope

Cleared under the same submission (K121914)

and 3 more cleared under K121914

Cleared under the same submission (K182887)

Similar devices in this category

Other devices filed under PULSE OXIMETERS.

Other devices from Masimo Corporation

See all devices from Masimo Corporation →

Properties

  • Measuring function
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)