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I-Stat Model 200 Portable Clinical Analyzer

by I-Stat Corp. 510(k)

Active United States

510(k) K001154

Overview

The I-Stat Model 200 Portable Clinical Analyzer is a blood gases (PCO2, PO2) and blood pH test system intended to measure certain gases in blood, serum, plasma or pH of blood, serum. This portable analyzer operates with test cartridges to deliver lab-quality diagnostic results at the patient's bedside.

The device is supplied by I-Stat Corp. and is authorized under FDA 510(k) K001154. It is designed for use in clinical chemistry settings and is classified as a Class II medical device. The analyzer is portable and intended for point-of-care testing of critical care parameters including blood gases, electrolytes, metabolites and coagulation.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK001154 Date18 Apr 2000ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

4 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0372-2008 FDA Unclassified (pre-2012) initiated 18 Oct 2007
    • Terminated Z-0375-2008 FDA Unclassified (pre-2012) initiated 18 Oct 2007
    • Terminated Z-0374-2008 FDA Unclassified (pre-2012) initiated 18 Oct 2007

    Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.

    • Terminated Z-0370-2008 FDA Unclassified (pre-2012) initiated 18 Oct 2007

    Difficult to Close -- Certian lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.

Specification

510(k)

510(k) Number
FDA Product Code
JGS
Device Class
Class II
Regulation
21 CFR Part 862.1665
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the I-Stat Model 200 Portable Clinical Analyzer used for?

    The I-Stat Model 200 is a blood gases and blood pH test system designed to measure certain gases in blood, serum, or plasma. It's intended for point-of-care testing of critical care parameters including blood gases, electrolytes, metabolites and coagulation in clinical chemistry settings.

  • How is the I-Stat Model 200 analyzer supplied?

    The device is supplied by I-Stat Corp. and operates with test cartridges to deliver lab-quality diagnostic results at the patient's bedside. It is designed for portability in clinical environments where immediate testing is required.

  • What is the regulatory classification of the I-Stat Model 200?

    The I-Stat Model 200 Portable Clinical Analyzer is classified as a Class II medical device and is authorized under FDA 510(k) K001154. It received a decision code of SESE, indicating it was determined to be substantially equivalent to predicate devices.

  • What testing parameters can the I-Stat Model 200 measure?

    This portable analyzer can measure blood gases (PCO2, PO2), blood pH, electrolytes, metabolites, and coagulation parameters. It provides lab-quality diagnostic results at the point of care, allowing clinicians to make immediate treatment decisions.