510(k) · Cleared
Clearedi-STAT Crea cartridge with the i-STAT 1 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Point of Care, Inc. · CGL Electrode, Ion Based, Enzymatic, Creatinine
Cleared on Jun 26, 2026 as substantially equivalent to K171059 (Nova Biomedical Corporation, 2017) after an 88-day review. Its family tree reaches back 2 generations to 2007.
- Decided
- Jun 26, 2026
- Review
- 88 days
- Class
- Class II
- Product code
- CGL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K070068 (2007). No later device cites it as a predicate yet.
- Root · 2 generations backK070068 Nova Statsensor Creatinine Hospital Meter, Control…Nova Biomedical Corp. · 2007 · Recalled
- 1 generation backK171059 Nova StatSensor Creatinine Hospital Meter SystemNova Biomedical Corporation · 2017
- This deviceK261039 i-STAT Crea cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K070068 | Nova Statsensor Creatinine Hospital Meter, Control Solutions,Linearity… | Nova Biomedical Corp. | 2007 | 5 |
| −1 | K171059 | Nova StatSensor Creatinine Hospital Meter System | Nova Biomedical Corporation | 2017 | — |
| 0 (this device) | K261039 | i-STAT Crea cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K171059 | Nova StatSensor Creatinine Hospital Meter SystemSummary page 5…Chemistry 3. Predicate Device Proprietary Name Nova StatSensor Creatinine Hospital Meter System 510(k) Number K171059 Product Regulation Device Classification Name… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 10.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K171059.
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. 2026, this device’s year, is highlighted.
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?
The i-STAT Crea cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of creatinine in
arterial, venous, or capillary whole blood in point of care or clinical laboratory settings.
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 as stated in the FDA summary.
https://510kreport.com/device/K261039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261039: i-STAT Crea cartridge with the i-STAT 1 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261039
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026