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Medex M20770R1

by ICU Medical, Inc.

Medex M20770R1 is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K943897 on 10 Feb 1995 (2 earlier submissions) and listed in FDA GUDID since 11 Oct 2016 (UDI-DI 10351688510655), active as of 23 Oct 2026. 8 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

8 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10351688510655 UDI-DI Date11 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK943897 Date10 Feb 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K943897 decided 10 Feb 1995 Active· +2 more in the status table
  • FDA GUDID UDI-DI 10351688510655 listed 11 Oct 2016 Listed

Recalls

9 recalls · 8 ongoing · FDA

  • 8 recalls, same reason

    • Ongoing Z-0743-2024 FDA Class II initiated 10 Nov 2023
    • Ongoing Z-0741-2024 FDA Class II initiated 10 Nov 2023
    • Ongoing Z-0742-2024 FDA Class II initiated 10 Nov 2023
    • Ongoing Z-0744-2024 FDA Class II initiated 10 Nov 2023
    • Ongoing Z-0739-2024 FDA Class II initiated 10 Nov 2023
    • Ongoing Z-0740-2024 FDA Class II initiated 10 Nov 2023
    • Ongoing Z-0747-2024 FDA Class II initiated 10 Nov 2023
    • Ongoing Z-0746-2024 FDA Class II initiated 10 Nov 2023

    There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.

    • Terminated Z-1549-2008 FDA Unclassified (pre-2012) initiated 24 Mar 2008 on shared 510(k) K790314

    Misbranded/mispackaged device was distributed. Product labeled to contain 72 inch Standard Drip ( IV) Administration Sets, actually contained 60 inch (IV) administration sets with a' Y' site.

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

Timeline

13 dated events

  1. Recall initiated FDA recalls Z-1549-2008
  2. Listed FDA GUDID 10351688510655
  3. Recall initiated FDA recalls Z-0743-2024
  4. Recall initiated FDA recalls Z-0741-2024
  5. Recall initiated FDA recalls Z-0742-2024
  6. Recall initiated FDA recalls Z-0744-2024
  7. Recall initiated FDA recalls Z-0739-2024
  8. Recall initiated FDA recalls Z-0740-2024
  9. Recall initiated FDA recalls Z-0747-2024
  10. Recall initiated FDA recalls Z-0746-2024

3 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
Medex
Generic name
Pressure transducer dome, single-use
Model / reference
M20770R1
Primary DI / UDI-DI
10351688510655
510(k) Number
FDA product code
FPA, FPB, DRS
GMDN term
Pressure transducer dome, single-use
Device class
Class II
Regulation number
880.5440, 870.2850
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Related devices

Category: Pressure transducer dome, single-use

Cleared under the same submission (K790314)

and 8 more cleared under K790314

Cleared under the same submission (K820355)

and 8 more cleared under K820355

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)