510(k) · Cleared
ClearedNova StatSensor Creatinine Hospital Meter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nova Biomedical Corporation · CGL Electrode, Ion Based, Enzymatic, Creatinine
Cleared on May 26, 2017 as substantially equivalent to K070068 (Nova Biomedical Corp., 2007) after a 46-day review. Its family tree reaches back 1 generation to 2007. 2 later devices descend from it.
- Decided
- May 26, 2017
- Review
- 46 days
- Class
- Class II
- Product code
- CGL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K070068 (2007). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK070068 Nova Statsensor Creatinine Hospital Meter, Control…Nova Biomedical Corp. · 2007 · Recalled
- This deviceK171059 Nova StatSensor Creatinine Hospital Meter SystemNova Biomedical Corporation · 2017
- Descendant · cites it directly · 0 of its ownK261039 i-STAT Crea cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK251281 Nova Max Creat eGFR Monitoring SystemNova Biomedical Corporation · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K070068 | Nova Statsensor Creatinine Hospital Meter, Control Solutions,Linearity… | Nova Biomedical Corp. | 2007 | 5 |
| 0 (this device) | K171059 | Nova StatSensor Creatinine Hospital Meter System | Nova Biomedical Corporation | 2017 | — |
| +1 | K261039 | i-STAT Crea cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2026 | — |
| +1 | K251281 | Nova Max Creat eGFR Monitoring System | Nova Biomedical Corporation | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 0 |
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.
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? (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 |
|---|---|---|---|
| * | K070068 | Nova Statsensor Creatinine Hospital Meter, Control Solutions,Linearity Solutions, and…Summary page 4…l Creatinine test system CGL(75) 862.1225 II Clinical Chemistry Product Codes: CGL, Electrode, Ion Based, Enzymatic, Creatinine Predicate Device: K070068 Nova StatSensor Creatinine Hospital Meter Device Description: The Nova StatSensor Creatinine Hospital Meter System consists of… | 2007 |
What descends from it? (2)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K261039 (Abbott Point of Care, Inc., 2026) 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. 2017, 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 Nova StatSensor Creatinine Hospital Meter System consists of the StatSensor Creatinine Hospital Meter and the StatSensor Creatinine Test Strips. The Nova StatSensor Creatinine Hospital Meter System is intended for in vitro diagnostic use by healthcare professionals and for Point-Of-Care usage for the quantitative measurement of creatinine in capillary, venous, and arterial whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis. Not for use in neonates.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171059: Nova StatSensor Creatinine Hospital Meter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171059
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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