510(k) · Cleared
Recalled · 2010I-Stat System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I-Stat Corp. · CGL Electrode, Ion Based, Enzymatic, Creatinine
Cleared on Oct 20, 1997 after a 48-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Oct 20, 1997
- Review
- 48 days
- Class
- Class II
- Product code
- CGL
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK973292 I-Stat SystemI-Stat Corp. · 1997
- Descendant · cites it directly · 0 of its ownK051968 ABL8X7 FlexRadiometer Medical Aps · 2006 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K051968ABL8X7 FlexRadiometer Medical Aps · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973292 | I-Stat System | I-Stat Corp. | 1997 | — |
| +1 | K051968 | ABL8X7 Flex | Radiometer Medical Aps | 2006 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CGL? 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 CGL device
- #1 K261039 i-STAT Crea cartridge with the i-STAT 1 Systemscore 11.9 · 2 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051968 | ABL8X7 Flex | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 17, 2010 | Not classified | Z-0456-2011 | Other | The i-STAT CREA Cartridges may produce inaccurate (depressed) results at or near the end of the labeled expiry date when stored above 25 degrees for 2 weeks. |
| Oct 18, 2007 | Not classified | Z-0373-2008 | Packaging change control | Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K051968 (Radiometer Medical Aps, 2006) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CGL devicesCGL Electrode, Ion Based, Enzymatic, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGL
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · CGL
Too few CGL 510(k)s in any year since 2007 to give a median.
Recalls per year · CGL
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGL
8in 2025
MAUDE reports naming product code CGL, 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 | — | 3 | 17 |
| 2008 | 0 | — | 1 | 3 |
| 2009 | 0 | — | 1 | 6 |
| 2010 | 0 | — | 1 | 12 |
| 2011 | 0 | — | 1 | 4 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 25 |
| 2020 | 0 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
For the quantitative determination of Creatinine (Crea) in whole blood with the i-STAT analyzer.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973292 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973292: I-Stat System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973292
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026