I-STAT 200 PORTABLE CLINICAL ANALYZER— 510(k) K940918

Name: FDA 510(k) clearance K940918
Creator: U.S. Food and Drug Administration
Published: 1994-05-10

Substantially Equivalent

I-Stat Corp.

FDA 510(k) clearance K940918 for I-STAT 200 PORTABLE CLINICAL ANALYZER, Substantially Equivalent on 1994-05-10. Applicant: I-Stat Corp.. Device class: 2.

Clearance details

Applicant: I-Stat Corp.
Product code: Code CHL
Device class: Class 2
Regulation: 21 CFR 862.1120
Advisory panel: Clinical Chemistry
Date received: 1994-02-25
Decision date: 1994-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CHL

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K252207 — ABL90 FLEX PLUS System, safeCLINITUBES2026-04-10
K244014 — i-STAT CG4+ cartridge with the i-STAT 1 System2025-05-02
K240998 — ABL90 FLEX PLUS System2024-12-13
K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System2023-10-27
K221900 — Stat Profile Prime Plus Analyzer System2023-09-29

More clearances from I-Stat Corp.

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K012478 — MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER2001-08-20
K011478 — I-STAT SYSTEM2001-07-02
K001387 — I-STAT PORTABLE CLINICAL ANALYZER, MODEL 3002000-10-05
K001154 — I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER2000-04-18
K992571 — I-STAT SYSTEM2000-02-10

Adverse events under product code CHL

product code CHL

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 →

Recalls naming K940918

K-number listed on FDA's recall record

Z-1999-2026 — i-STAT EG7+ cartridge; List Number: 03P76-25;Class II·Ongoing·Abbott Point Of Care Inc.·20260401
Z-2000-2026 — i-STAT EG6+ cartridge; List Number: 03P77-25;Class II·Ongoing·Abbott Point Of Care Inc.·20260401
Z-2582-2025 — i-STAT CG4+ cartridge (white). List Number: 03P85-25.Class II·Ongoing·Abbott Point Of Care Inc.·20250821
Z-0880-2021 — Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood List Number: 03P88-25Class II·Terminated·Abbott Point Of Care Inc.·20201222
Z-0881-2021 — Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood. List Number: 03P76-25Class II·Terminated·Abbott Point Of Care Inc.·20201222
Z-0615-2019 — Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood. List Number/UDI# : 03P88-25 ,(01)10054749000163(17)181028(10)L18059Class II·Terminated·Abbott Point Of Care Inc.·20180913
Z-1306-2014 — i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.Class II·Terminated·Abbott Point Of Care Inc.·20140101
Z-2133-2012 — I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, partial pressure in arterial, venous, or capillary whole blood.Class II·Terminated·Abbott Point Of Care Inc.·20110101

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K940918.

Data sourced from openFDA. This site is unofficial and independent of the FDA.