MEDEX MACHINE— 510(k) K880032

Clearance details

Applicant

Medex, Inc.

Product code

Code ISD

Device class

Class 2

Regulation

21 CFR 890.5360

Advisory panel

Physical Medicine

Date received

1988-01-05

Decision date

1988-02-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Ocala, FL, US

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• K112121 — ERGOSELECT/GE2012-10-31
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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

Other

2

Total

2

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-0935-2015 — Lumbar Extension Machine for Physical TherapyClass II·Terminated·MedX Holdings, Inc.·20131203

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K880032.