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Truwave K16912A

by Edwards Lifesciences LLC

Ref K16912A

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0690103D001TDA000SS Basic UDI-DI 07460691950382UDI-DIDate24 Sep 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK171996 Date23 Oct 2017DecidedStatusActive
United StatesGUDID listing GUDID Number07460691950382 UDI-DI Date3 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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.

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 blood pressure monitoring tubing set
Device name
TruWave Pressure Monitoring Kit Additional accessories
Model / Ref / Catalog
K16912A
Primary DI / UDI-DI
07460691950382
Basic UDI-DI
0690103D001TDA000SS
510(k) Number
FDA product code
DXO
EMDN code
Z1203020301 Invasive blood pressure monitoring instruments
GMDN term
Invasive blood pressure monitoring tubing set
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
Size
Length — 12 Inch

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Invasive blood pressure monitoring tubing set

Cleared under the same submission (K142749)

Show all (12)

Cleared under the same submission (K171996)

Show all (12)

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

  • Supplied sterile
  • Single use
  • Administering medicine
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (17)

  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No