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OptoMonitor 3

by Opsens

Part of a family of 20 devices: see the family page

Ref F201222Model Pressure Output Cable

OptoMonitor 3 (F201222) is a device classified as Class I in the EU and Class II in the US made by Opsens, registered in EUDAMED on 9 Oct 2026 (Basic UDI-DI 07540184F2012ZW), cleared under FDA 510(k) K251367 on 16 Jan 2026 (3 earlier submissions) and listed in FDA GUDID since 4 May 2026 (UDI-DI 07540184012220), active as of 25 Oct 2026.

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 found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K251367

+3 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number07540184F2012ZW Basic UDI-DI 07540184012220UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07540184012220 UDI-DI Date4 May 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK251367 Date16 Jan 2026IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 07540184F2012ZW registered 9 Oct 2026 Active
  • FDA 510(k) K251367 decided 16 Jan 2026 Active· +3 more in the status table
  • FDA GUDID UDI-DI 07540184012220 listed 4 May 2026 Listed

Timeline

6 dated events

  1. Cleared FDA 510(k) K202943
  2. Cleared FDA 510(k) K213854
  3. Cleared FDA 510(k) K241418
  4. Cleared FDA 510(k) K251367
  5. Listed FDA GUDID 07540184012220
  6. Registered EUDAMED 07540184F2012ZW

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  • Withdrawn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
Pressure out cable Nihon Kohden 15 pins connector EUDAMED
OptoMonitor 3 GUDID
Generic name
Cardiac catheterization laboratory computer
Device name
Pressure out cable Philips/WITT
Model / Ref / Catalog
Pressure Output Cable, F201222, Pressure output cable - Nihon Kohden 15 pins
Primary DI / UDI-DI
07540184012220
Basic UDI-DI
07540184F2012ZW
510(k) Number
FDA product code
DXO
EMDN code
Z12050580 Cardiac output measurement instruments - hardware accessories
GMDN term
Cardiac catheterization laboratory computer
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.2870
EU registration type
Standard device
EU market of registration
Hungary
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Pressure Output Cable
F201222
GUDID
Pressure output cable - Nihon Kohden 15 pins
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

Cleared under the same submission (K202943)

and 8 more cleared under K202943

Cleared under the same submission (K213854)

and 8 more cleared under K213854

Similar devices in this category

Other devices filed under CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Opsens

See all devices from Opsens →

Properties

  • Prescription use
Other properties (24, all answered No)