AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR)— 510(k) K042642

Clearance details

Applicant

Ge Medical Systems Information Technologies

Product code

Code MHX

Device class

Class 2

Regulation

21 CFR 870.1025

Advisory panel

Cardiovascular

Date received

2004-09-27

Decision date

2004-11-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Milwaukee, WI, US

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Death

580

Injury

2,441

Malfunction

12,655

Other

3

Total

15,679

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-2015-2012 — GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004.Class II·Terminated·GE Healthcare, LLC·20120612

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042642.