# K940918: I-Stat 200 Portable Clinical Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: I-Stat Corp.
- Decided: May 10, 1994 after 74 days
- Product code: CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph)
- Device class: 2
- Regulation: 21 CFR 862.1120
- Recalls of this device: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K990092: Avl Omni Modular Analyzer (1999), 7 descendants of its own
- K974784: Avl Opti Critical Care Analyzer (1998), 5 descendants of its own
- K984299: Avl Opti Critical Care Analyzer (1998), 4 descendants of its own
- K013373: Omni C Analyzer (2001), 2 descendants of its own
- K993837: Avl Opti Critical Care Analyzer (1999), 2 descendants of its own

## Recalls of this device
- Apr 1, 2026 · Class II · Z-2000-2026: Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may r
- Apr 1, 2026 · Class II · Z-1999-2026: Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may r
- Aug 21, 2025 · Class II · Z-2582-2025: Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.
- Dec 22, 2020 · Class II · Z-0880-2021: Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3 days for l
- Dec 22, 2020 · Class II · Z-0881-2021: Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3 days for l
- Sep 13, 2018 · Class II · Z-0615-2019: Inaccurate potassium results may be generated. When testing with control fluid and/or patient samples with low or reference range potassium concentration, elevated potassium results may be generated. 
- Jan 1, 2014 · Class II · Z-1306-2014: Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 and depressed pH res
- Jan 1, 2011 · Class II · Z-2133-2012: i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when stored at room temperature for four weeks or longer.
- Sep 20, 2010 · Not classified · Z-0594-2011: i-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.
- Sep 20, 2010 · Not classified · Z-0596-2011: i-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.
- Sep 20, 2010 · Not classified · Z-0593-2011: i-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.
- Sep 20, 2010 · Not classified · Z-0595-2011: i-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.
- Aug 3, 2010 · Not classified · Z-0929-2011: Two cartridge lots were identified that may generate falsely elevated PCO2 results.
- Aug 3, 2010 · Not classified · Z-0930-2011: Two cartridge lots were identified that may generate falsely elevated PCO2 results.
- Feb 5, 2010 · Not classified · Z-1793-2010: Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.
- Feb 5, 2010 · Not classified · Z-1794-2010: Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.
- Feb 23, 2009 · Not classified · Z-1540-2009: Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals.
- Feb 23, 2009 · Not classified · Z-1541-2009: Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals.
- Sep 25, 2006 · Not classified · Z-1621-2011: Certain lots of G3+ cartridges may be difficult to fill.

Source page: https://510kreport.com/device/K940918
Methodology: https://510kreport.com/methodology