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Medex MX20103R1

by ICU Medical, Inc.

Medex MX20103R1 is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K942377 on 16 Aug 1994 and listed in FDA GUDID since 11 Oct 2016 (UDI-DI 10351688551696), active as of 23 Oct 2026. 3 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

3 ongoing

This device is named in the recall

Documents

510(k) K942377

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10351688551696 UDI-DI Date11 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK942377 Date16 Aug 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K942377 decided 16 Aug 1994 Active
  • FDA GUDID UDI-DI 10351688551696 listed 11 Oct 2016 Listed

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-0185-2025 FDA Class II initiated 24 Sep 2024
    • Ongoing Z-0184-2025 FDA Class II initiated 24 Sep 2024
    • Ongoing Z-0186-2025 FDA Class II initiated 24 Sep 2024

    Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

Timeline

5 dated events

  1. Cleared FDA 510(k) K942377
  2. Listed FDA GUDID 10351688551696
  3. Recall initiated FDA recalls Z-0185-2025
  4. Recall initiated FDA recalls Z-0184-2025
  5. Recall initiated FDA recalls Z-0186-2025

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  • Withdrawn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
Invasive-pressure external transducer, single-use
Model / reference
MX20103R1
Primary DI / UDI-DI
10351688551696
510(k) Number
FDA product code
DPT
GMDN term
Invasive-pressure external transducer, single-use
Device class
Class II
Regulation number
870.2120
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Related devices

Category: Invasive-pressure external transducer, single-use

Cleared under the same submission (K942377)

and 8 more cleared under K942377

Similar devices in this category

Other devices filed under Invasive-pressure external transducer, single-use.

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

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