EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER— 510(k) K021515

Clearance details

Applicant

Medica Corp.

Product code

Code CHL

Device class

Class 2

Regulation

21 CFR 862.1120

Advisory panel

Clinical Chemistry

Date received

2002-05-10

Decision date

2002-07-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bedford, MA, US

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• K112788 — EASTLYTE NA/K/CA/PH2011-10-20

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-1370-2026 — Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.Class II·Ongoing·Medica Corporation·20251231

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021515.