Name: FDA 510(k) clearance K951129
Creator: U.S. Food and Drug Administration
Published: 1995-04-05

Clearance details

Applicant: Medex, Inc.
Product code: Code DRS
Device class: Class 2
Regulation: 21 CFR 870.2850
Advisory panel: Cardiovascular
Date received: 1995-03-13
Decision date: 1995-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hilliard, OH, US

Recent devices under product code DRS

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K254074 — TruPress2026-09-10
K242909 — FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors2025-03-21
K221782 — Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes2023-03-17
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

More clearances from Medex, Inc.

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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

Adverse events under product code DRS

product code DRS

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 →