510(k) · Cleared
Recalled · Class II · 2026I-Stat 200 Portable Clinical Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I-Stat Corp. · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on May 10, 1994 after a 74-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 11 later devices descend from it. It has been recalled 19 times.
- Decided
- May 10, 1994
- Review
- 74 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 19
- Predicates
- 0
11 later devices descend from it, 5 citing it directly.
- This deviceK940918 I-Stat 200 Portable Clinical AnalyzerI-Stat Corp. · 1994
- Descendant · cites it directly · 7 of its ownK990092 Avl Omni Modular AnalyzerAvl Scientific Corp. · 1999 · Recalled
- Descendant · cites it directly · 5 of its ownK974784 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998
- Descendant · cites it directly · 4 of its ownK984299 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998
- Descendant · 2 generations on · 2 of its ownK013373 Omni C AnalyzerRoche Diagnostics Corp. · 2001 · Recalled
- Descendant · cites it directly · 2 of its ownK993837 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1999
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K990092Avl Omni Modular AnalyzerAvl Scientific Corp. · 1999 · cites it directly7descendants
- K974784Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998 · cites it directly5descendants
- K984299Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998 · cites it directly4descendants
- K013373Omni C AnalyzerRoche Diagnostics Corp. · 2001 · 2 generations on2descendants
- K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1999 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940918 | I-Stat 200 Portable Clinical Analyzer | I-Stat Corp. | 1994 | — |
| +1 | K990092 | Avl Omni Modular Analyzer | Avl Scientific Corp. | 1999 | 4 |
| +1 | K974784 | Avl Opti Critical Care Analyzer | Avl Scientific Corp. | 1998 | — |
| +1 | K984299 | Avl Opti Critical Care Analyzer | Avl Scientific Corp. | 1998 | — |
| +2 | K013373 | Omni C Analyzer | Roche Diagnostics Corp. | 2001 | 1 |
| +1 | K993837 | Avl Opti Critical Care Analyzer | Avl Scientific Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CHL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CHL device
- #1 K252207 ABL90 FLEX PLUS System, safeCLINITUBESscore 14.2 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 1, 2026 | Class II | Z-2000-2026 | Process change control | 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 report higher than expected PCO2 and… |
| Apr 1, 2026 | Class II | Z-1999-2026 | Process change control | 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 report higher than expected PCO2 and… |
| Aug 21, 2025 | Class II | Z-2582-2025 | No Marketing Application | 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 | Under Investigation by firm | 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 lot numbers *20100 to *20339 and 7 days… |
| Dec 22, 2020 | Class II | Z-0881-2021 | Under Investigation by firm | 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 lot numbers *20100 to *20339 and 7 days… |
| Sep 13, 2018 | Class II | Z-0615-2019 | Manufacturing material removal | 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. When testing with samples with a high… |
| Jan 1, 2014 | Class II | Z-1306-2014 | Process control | 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 results. |
| Jan 1, 2011 | Class II | Z-2133-2012 | Nonconforming Material/Component | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | Two cartridge lots were identified that may generate falsely elevated PCO2 results. |
| Aug 3, 2010 | Not classified | Z-0930-2011 | Other | Two cartridge lots were identified that may generate falsely elevated PCO2 results. |
| Feb 5, 2010 | Not classified | Z-1793-2010 | Other | 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 | Other | 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 | Packaging process control | 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 | Packaging process control | 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 | Other | Certain lots of G3+ cartridges may be difficult to fill. |
The 5 latest of 19 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K990092 (Avl Scientific Corp., 1999) has gone furthest, with 7 descendants of its own.
How does its category compare?
All CHL devicesCHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CHL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHL
267in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHL
13so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHL
210in 2025
MAUDE reports naming product code CHL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 6 | 16 |
| 2008 | 1 | — | 5 | 40 |
| 2009 | 0 | — | 6 | 74 |
| 2010 | 1 | — | 7 | 20 |
| 2011 | 4 | 108 | 1 | 50 |
| 2012 | 4 | 65 | 9 | 64 |
| 2013 | 5 | 152 | 1 | 62 |
| 2014 | 3 | 68 | 1 | 93 |
| 2015 | 4 | 155 | 3 | 55 |
| 2016 | 3 | 306 | 1 | 118 |
| 2017 | 1 | — | 1 | 206 |
| 2018 | 1 | — | 3 | 174 |
| 2019 | 0 | — | 0 | 141 |
| 2020 | 4 | 100 | 2 | 117 |
| 2021 | 2 | — | 0 | 147 |
| 2022 | 0 | — | 0 | 138 |
| 2023 | 5 | 267 | 4 | 177 |
| 2024 | 1 | — | 9 | 196 |
| 2025 | 1 | — | 0 | 210 |
| 2026 | 1 | — | 13 | — |
https://510kreport.com/device/K940918 · printed Nov 4, 2026
Cite this page
510(k) Report. “K940918: I-Stat 200 Portable Clinical Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K940918
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026