510(k) · Cleared
Recalled · Class I · 2013Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max Blood Glucos
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nova Biomedical Corp. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jan 15, 2010 as substantially equivalent to K070255 (Nova Biomedical Corp., 2007) and 1 other predicate after a 233-day review. Its family tree reaches back 6 generations to 1995. 1 of the 24 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it. It has been recalled 10 times, including 10 Class I recalls.
- Decided
- Jan 15, 2010
- Review
- 233 days
- Class
- Class II
- Product code
- NBW
- Recalls
- 10 (10 Class I)
- Predicates
- 2
Its longest line of descent runs back 6 generations to K945887 (1995). 13 ancestors in all, the oldest K850368 (1985). 10 later devices descend from it, 7 citing it directly. 1 of the 24 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 5 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 4 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 3 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 2 generations backK983504 Precision Xtra Advanced Diabetes Management System, Precision Blood…Medisense, Inc. · 1999 · Recalled
- 1 generation backK040814 Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories · 2004 · Recalled
- This deviceK091547 Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max…Nova Biomedical Corp. · 2010
- Descendant · cites it directly · 2 of its ownK161738 FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and…Taidoc Technology Corporation · 2016
- Descendant · cites it directly · 1 of its ownK170463 KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood…I-Sens, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK201037 FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation · 2022
- Descendant · cites it directly · 0 of its ownK202534 MTM301 Blood Glucose and Ketone Monitoring SystemApex BioTechnology Corp. · 2022
- Descendant · cites it directly · 0 of its ownK201880 MultiSure GK Link Blood Glucose and Ketone Monitoring SystemApex BioTechnology Corp. · 2021
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring…Taidoc Technology Corporation · 2016 · cites it directly2descendants
- K170463KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemI-Sens, Inc. · 2018 · cites it directly1descendant
- K201037FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation · 2022 · 2 generations on0descendants
- K202534MTM301 Blood Glucose and Ketone Monitoring SystemApex BioTechnology Corp. · 2022 · cites it directly0descendants
- K201880MultiSure GK Link Blood Glucose and Ketone Monitoring SystemApex BioTechnology Corp. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −5 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −4 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −3 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −2 | K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose… | Medisense, Inc. | 1999 | 1 |
| −1 | K040814 | Modification to Precision Xtra Advanced Diabetes Management System | Abbott Laboratories | 2004 | 3 |
| 0 (this device) | K091547 | Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus… | Nova Biomedical Corp. | 2010 | — |
| +1 | K161738 | FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone… | Taidoc Technology Corporation | 2016 | — |
| +1 | K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone… | I-Sens, Inc. | 2018 | — |
| +2 | K201037 | FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System | Taidoc Technology Corporation | 2022 | — |
| +1 | K202534 | MTM301 Blood Glucose and Ketone Monitoring System | Apex BioTechnology Corp. | 2022 | — |
| +1 | K201880 | MultiSure GK Link Blood Glucose and Ketone Monitoring System | Apex BioTechnology Corp. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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.
1 device in this family has a Class I recall. 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 NBW device
- #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K070255 | Nova Max Blood Glucose Monitor System, 90001,90002Summary page 1…2.1345 Ketone Test System Class I per 21 CER 862.1435 Product Codes: NBW, CGA, JIN, JJX Predicate Devices: Nova.Max Blood GlucoseMonitor, K070255, Precision Xtra Advanced Diabetes Management System,k0408l14 Description of the Device:. The Nova Max Plus Blood… | 2007 |
| * | K040814 | Modification to Precision Xtra Advanced Diabetes Management SystemSummary page 2…ax Plus Blood Glucose and Ketone Monitoring System is substantially equivalent to the predicate device,.Precision Xtra Advanced Diabetes Management System, K0408 14, for ketone measurements. The Nova Max Plus Blood Glucose and P-Ketone Monitoring System measures glucose e… | 2004 |
What descends from it? (10)
7 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161738 | FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring… | 2016 | 2 |
| K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System | 2018 | 1 |
| K202534 | MTM301 Blood Glucose and Ketone Monitoring System | 2022 | 0 |
| K201880 | MultiSure GK Link Blood Glucose and Ketone Monitoring System | 2021 | 0 |
| K182593 | KET-1 Blood Ketone Monitoring System | 2018 | 0 |
| K122688 | Nova Max Mini Blood Glucose and B-Ketone Monitor | 2013 | 0 |
| K101633 | Nova Max Plus Glocose and B-Ketone Control Solution-Mid, High | 2010 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 15, 2013 | Class I | Z-1901-2013 | Material/Component Contamination | Reports of false abnormally high glucose readings from test strips |
| Jul 15, 2013 | Class I | Z-1905-2013 | Material/Component Contamination | Reports of false abnormally high glucose readings from test strips |
| Jul 15, 2013 | Class I | Z-1897-2013 | Material/Component Contamination | Reports of false abnormally high glucose readings from test strips |
| Jul 15, 2013 | Class I | Z-1902-2013 | Material/Component Contamination | Reports of false abnormally high glucose readings from test strips |
| Jul 15, 2013 | Class I | Z-1903-2013 | Material/Component Contamination | Reports of false abnormally high glucose readings from test strips |
| Jul 15, 2013 | Class I | Z-1899-2013 | Material/Component Contamination | Reports of false abnormally high glucose readings from test strips |
| Jul 15, 2013 | Class I | Z-1898-2013 | Material/Component Contamination | Reports of false abnormally high glucose readings from test strips |
| Jul 15, 2013 | Class I | Z-1906-2013 | Material/Component Contamination | Reports of false abnormally high glucose readings from test strips |
| Jul 15, 2013 | Class I | Z-1900-2013 | Material/Component Contamination | Reports of false abnormally high glucose readings from test strips |
| Jul 15, 2013 | Class I | Z-1904-2013 | Material/Component Contamination | Reports of false abnormally high glucose readings from test strips |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K161738 (Taidoc Technology Corporation, 2016) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K070255.
How does its category compare?
All NBW devicesNBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NBW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBW
243in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBW
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NBW
4,745in 2025
MAUDE reports naming product code NBW, 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 | 29 | 85 | 9 | 7,991 |
| 2008 | 37 | 128 | 2 | 7,704 |
| 2009 | 38 | 140 | 5 | 10,963 |
| 2010 | 31 | 132 | 11 | 11,631 |
| 2011 | 30 | 328 | 1 | 22,909 |
| 2012 | 30 | 230 | 1 | 23,449 |
| 2013 | 47 | 167 | 5 (2) | 35,408 |
| 2014 | 24 | 202 | 1 | 38,524 |
| 2015 | 32 | 237 | 0 | 62,111 |
| 2016 | 20 | 233 | 1 | 76,621 |
| 2017 | 25 | 244 | 0 | 37,538 |
| 2018 | 19 | 168 | 0 | 16,911 |
| 2019 | 10 | 127 | 14 | 14,472 |
| 2020 | 7 | 121 | 0 | 10,703 |
| 2021 | 7 | 465 | 0 | 9,198 |
| 2022 | 12 | 410 | 0 | 8,103 |
| 2023 | 5 | 193 | 0 | 7,256 |
| 2024 | 7 | 243 | 0 | 6,220 |
| 2025 | 2 | — | 1 | 4,745 |
| 2026 | 5 | 190 | 0 | — |
What is it indicated for?
The Nova Max Plus Blood Glucose and β-Ketone Monitoring System Monitor is intended to be used for the quantitative measurement of glucose or β-hydroxybutyrate (β-ketone) in fresh capillary whole blood. It is intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes…
Read the full statement (316 words)
The Nova Max Plus Blood Glucose and β-Ketone Monitoring System Monitor is intended to be used for the quantitative measurement of glucose or β-hydroxybutyrate (β-ketone) in fresh capillary whole blood. It is intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The Nova Max Blood Glucose and β-Ketone Monitor is specifically indicated for the quantitative measurement of glucose in fresh capillary whole blood samples obtained from the fingertip, forearm and palm or β-hydroxybutyrate (β-ketone) in fresh capillary whole blood obtained from the fingertip only.
Nova Max Glucose Test Strips are intended for use only with the Nova Max Blood Glucose Monitor and the Nova Max Plus Blood Glucose and β-Ketone Monitor. The Glucose Monitor is calibrated to provide plasma equivalent glucose results to laboratory methods. Nova Max Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use only).
The Nova Max Plus Ketone Test Strips are intended for use only on the Nova Max Plus Blood Glucose and β-Ketone Monitor.
Nova Max Glucose Control Solutions are intended for use with the Nova Max Blood Glucose Monitor and the Nova Max Plus Blood Glucose and β-Ketone Monitor and Nova Max Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. There are three levels of glucose controls, (Normal, Low, High).
Nova Max Plus Ketone Control Solutions are intended for use with the Nova Max Plus Blood Glucose and β-Ketone Monitor and the Nova Max Plus Ketone Test Strips as a quality control check to verify the accuracy of blood ketone test results. There are three levels of ketone controls, (Levels 1, 2 and 3).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091547 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091547: Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max Blood Glucos.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091547
Report an extraction error
Are you the manufacturer?
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