510(k) · Cleared
ClearedNova Max Creat eGFR Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nova Biomedical Corporation · SHB Creatinine Test System For At Home Prescription Use
Cleared on Jan 21, 2026 as substantially equivalent to K171059 (Nova Biomedical Corporation, 2017) after a 272-day review. Its family tree reaches back 2 generations to 2007.
- Decided
- Jan 21, 2026
- Review
- 272 days
- Class
- Class II
- Product code
- SHB
- 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 deviceK251281 Nova Max Creat eGFR Monitoring SystemNova Biomedical Corporation · 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) | K251281 | Nova Max Creat eGFR Monitoring System | Nova Biomedical Corporation | 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 SHB? 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…Number Panel Creatinine test system SHB 862.1225 Class II Clinical Chemistry Predicate Device K171059, Nova StatSensor Creatinine Hospital Meter System Page 1 of 7 Device Description The Nova Max Creat eGFR Mon… | 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 2 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 SHB devicesSHB Creatinine Test System For At Home Prescription Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SHB
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SHB
Too few SHB 510(k)s in any year since 2007 to give a median.
Recalls per year · SHB
No recall names SHB since 2007.
Adverse event reports per year · SHB
No MAUDE report names SHB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Nova Max Creat eGFR Monitoring System is comprised of the Nova Max Creat eGFR Monitor and the Nova Max Creat eGFR Test Strips.
The Nova Max Creat eGFR Monitoring System is intended for in vitro diagnostic use for the quantitative measurement of creatinine and estimation of glomerular filtration rate (eGFR) in fresh capillary whole blood obtained from the fingertip of adult patients aged 18 and above. The system is intended for single patient home use by prescription only and should not be shared. It is intended for use by patients as an aid to monitor kidney function on the order of a treating healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251281: Nova Max Creat eGFR Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251281
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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