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Truwave MK2220

by Edwards Lifesciences LLC

Truwave MK2220 is a Class II device made by Edwards Lifesciences LLC, cleared under FDA 510(k) K171996 on 23 Oct 2017 (1 earlier submission) and listed in FDA GUDID since 3 Sep 2016 (UDI-DI 00690103148190), active as of 22 Oct 2026. 9 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

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

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK171996 Date23 Oct 2017DecidedStatusActive
United StatesGUDID listing Number00690103148190 UDI-DI Date3 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K171996 decided 23 Oct 2017 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00690103148190 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

14 dated events

  1. Recall initiated FDA recalls Z-1961-2021
  2. Recall initiated FDA recalls Z-1966-2021
  3. Recall initiated FDA recalls Z-1962-2021
  4. Recall initiated FDA recalls Z-1963-2021
  5. Recall initiated FDA recalls Z-1965-2021
  6. Recall initiated FDA recalls Z-1964-2021
  7. Recall initiated FDA recalls Z-1959-2021
  8. Recall initiated FDA recalls Z-1960-2021
  9. Recall initiated FDA recalls Z-0414-2024
  10. Recall initiated FDA recalls Z-0413-2024

4 earlier events are in the sections above.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Truwave
Generic name
Invasive blood pressure monitoring tubing set
Model / Ref / Catalog
MK2220
Primary DI / UDI-DI
00690103148190
510(k) Number
FDA product code
DXO
GMDN term
Invasive blood pressure monitoring tubing set
Device class
Class II
Regulation number
870.2870
GUDID distribution status
In Commercial Distribution

Related devices

Category: Invasive blood pressure monitoring tubing setCable/lead/sensor/probe cover, sterile

Cleared under the same submission (K142749)

and 8 more cleared under K142749

Cleared under the same submission (K171996)

and 8 more cleared under K171996

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)