MX960 REUSABLE PRESSURE TRANSDUCER— 510(k) K961404

Clearance details

Applicant

Medex, Inc.

Product code

Code DRS

Device class

Class 2

Regulation

21 CFR 870.2850

Advisory panel

Cardiovascular

Date received

1996-04-11

Decision date

1996-06-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Dublin, OH, US

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• K172458 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit2017-11-09
• K163172 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit2017-05-24

• K042432 — PHARMGUARD TOOLBOX, MODEL G60007822005-01-04
• K040899 — MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP2004-04-30
• K020780 — TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP2002-05-20
• K000328 — MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP2000-05-09
• K982640 — MEDEX 3000 SERIES SYRINGE INFUSION PUMP1999-04-06

Death

8

Malfunction

776

Total

784

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1470-2021 — LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.Class II·Terminated·Smiths Medical ASD Inc.·20210331
• Z-1471-2021 — Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood sampling.Class II·Terminated·Smiths Medical ASD Inc.·20210331
• Z-1473-2021 — LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.Class II·Terminated·Smiths Medical ASD Inc.·20210331
• Z-1474-2021 — Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid flow.Class II·Terminated·Smiths Medical ASD Inc.·20210331
• Z-1477-2021 — Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number MX1431MRL c. 700 PSI STPCK W/ ROTATOR, Model Number MX4331R. Stopcocks and manifolds used to control the direction of IV fluid flow.Class II·Terminated·Smiths Medical ASD Inc.·20210331

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K961404.