GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)— 510(k) K160412

Clearance details

Applicant

Instrumentation Laboratory CO

Product code

Code CHL

Device class

Class 2

Regulation

21 CFR 862.1120

Advisory panel

Clinical Chemistry

Date received

2016-02-12

Decision date

2016-12-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bedford, MA, US

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Death

20

Malfunction

999

Total

1,019

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-1535-2026 — GEM Premier 5000; Part No. 00055415010.Class II·Ongoing·Instrumentation Laboratory·20260120

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160412.