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Truwave 50P200R

by Edwards Lifesciences LLC

Part of a family of 15 devices: see the family page

Ref 50P200R

Truwave 50P200R is a device classified as Class IIa in the EU and Class II in the US made by Edwards Lifesciences LLC, registered in EUDAMED on 24 Sep 2026 (Basic UDI-DI 0690103D001TDA000SS), cleared under FDA 510(k) K171996 on 23 Oct 2017 (1 earlier submission) and listed in FDA GUDID since 3 Sep 2016 (UDI-DI 07460691951990), active as of 24 Oct 2026. 9 FDA recalls are 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

2 ongoing

Recall on shared 510(k) K142749; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K171996

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0690103D001TDA000SS Basic UDI-DI 07460691951990UDI-DIDate24 Sep 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK171996 Date23 Oct 2017DecidedStatusActive
United StatesGUDID listing GUDID Number07460691951990 UDI-DI Date3 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0690103D001TDA000SS registered 24 Sep 2026 Active
  • FDA 510(k) K171996 decided 23 Oct 2017 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07460691951990 listed 3 Sep 2016 Listed

Recalls

11 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0414-2024 FDA Class II initiated 4 Oct 2023 on shared 510(k) K142749
    • Ongoing Z-0413-2024 FDA Class II initiated 4 Oct 2023 on shared 510(k) K142749

    Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

  • 8 recalls, same reason

    • Terminated Z-1961-2021 FDA Class II initiated 26 May 2021
    • Terminated Z-1966-2021 FDA Class II initiated 26 May 2021
    • Terminated Z-1962-2021 FDA Class II initiated 26 May 2021
    • Terminated Z-1963-2021 FDA Class II initiated 26 May 2021
    • Terminated Z-1965-2021 FDA Class II initiated 26 May 2021
    • Terminated Z-1964-2021 FDA Class II initiated 26 May 2021
    • Terminated Z-1959-2021 FDA Class II initiated 26 May 2021
    • Terminated Z-1960-2021 FDA Class II initiated 26 May 2021

    There is a potential that the pressure tubing may detach from the blood sampling system

    • Terminated Z-2776-2015 FDA Class II initiated 31 Jul 2015

    Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

15 dated events

  1. Recall initiated FDA recalls Z-1966-2021
  2. Recall initiated FDA recalls Z-1962-2021
  3. Recall initiated FDA recalls Z-1963-2021
  4. Recall initiated FDA recalls Z-1965-2021
  5. Recall initiated FDA recalls Z-1964-2021
  6. Recall initiated FDA recalls Z-1959-2021
  7. Recall initiated FDA recalls Z-1960-2021
  8. Recall initiated FDA recalls Z-0414-2024
  9. Recall initiated FDA recalls Z-0413-2024
  10. Registered EUDAMED 0690103D001TDA000SS

5 earlier events are in the sections above.

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
Truwave
Generic name
Invasive-pressure external transducer, single-use
Device name
TruWave Pressure Monitoring Kit Additional accessories
Model / Ref / Catalog
50P200R
Primary DI / UDI-DI
07460691951990
Basic UDI-DI
0690103D001TDA000SS
510(k) Number
FDA product code
DXO
EMDN code
Z1203020301 Invasive blood pressure monitoring instruments
GMDN term
Invasive-pressure external transducer, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.2870
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Invasive-pressure external transducer, single-useLuer/Luer linear connector, single-use

Cleared under the same submission (K142749)

and 8 more cleared under K142749

Cleared under the same submission (K171996)

and 8 more cleared under K171996

Similar devices in this category

Other devices filed under INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS.

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

  • Supplied sterile
  • Single use
  • Administering medicine
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)