Skip to content

Medex MX9515

by ICU Medical, Inc.

Medex MX9515 is a Class I device made by ICU Medical, Inc., cleared under FDA 510(k) K070340 on 15 Mar 2007 (1 earlier submission) and listed in FDA GUDID since 7 Dec 2016 (UDI-DI 10351688503671), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10351688503671 UDI-DI Date7 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK070340 Date15 Mar 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K070340 decided 15 Mar 2007 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10351688503671 listed 7 Dec 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

6 dated events

  1. Cleared FDA 510(k) K942377
  2. Cleared FDA 510(k) K070340
  3. Listed FDA GUDID 10351688503671
  4. Recall initiated FDA recalls Z-0185-2025
  5. Recall initiated FDA recalls Z-0184-2025
  6. 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  • Withdrawn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
MX9515
Primary DI / UDI-DI
10351688503671
510(k) Number
FDA product code
CBT, DPT
GMDN term
Invasive-pressure external transducer, single-use
Device class
Class I
Regulation number
868.1100, 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 (K070340)

and 8 more cleared under K070340

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)