510(k) · Cleared
ClearedNova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nova Biomedical Corporation · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Mar 9, 2012 as substantially equivalent to K070255 (Nova Biomedical Corp., 2007) and 2 other predicates after a 182-day review. Its family tree reaches back 9 generations to 1995. 1 of the 34 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Mar 9, 2012
- Review
- 182 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K945887 (1995). 30 ancestors in all, the oldest K896951 (1990). 3 later devices descend from it, 2 citing it directly. 1 of the 34 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 5 generations between
- 3 generations backK050500 Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2005
- 2 generations backK051839 Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc. · 2006 · Recalled
- 1 generation backK092638 Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01…Abbott Diabetes Care, Inc. · 2010 · Recalled (Class I)
- This deviceK112638 Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test…Nova Biomedical Corporation · 2012
- Descendant · cites it directly · 1 of its ownK122435 Nova One Blood Glucose MonitorNova Biomedical Corporation · 2012
- Descendant · 2 generations on · 0 of its ownK131013 Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose…Nova Biomedical Corporation · 2013
- Descendant · cites it directly · 0 of its ownK122688 Nova Max Mini Blood Glucose and B-Ketone MonitorNova Biomedical Corporation · 2013
Show all 9 generations
- Root · 9 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 8 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 7 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 6 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 5 generations backK982303 Precision PCX Point of Care Management System , QC Manager Data…Medisense, Inc. · 1998
- 4 generations backK022941 Medisense Precision PCX Point of Care Management System for Blood…Abbott Laboratories · 2002
- 3 generations backK050500 Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2005
- 2 generations backK051839 Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc. · 2006 · Recalled
- 1 generation backK092638 Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01…Abbott Diabetes Care, Inc. · 2010 · Recalled (Class I)
- This deviceK112638 Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test…Nova Biomedical Corporation · 2012
Class I recalls in this family
- K092638 Freestyle Blood Glucose Test Strips, Models…direct predicate · 2010
Most influential descendants
Showing 3 of 3 · See all- K122435Nova One Blood Glucose MonitorNova Biomedical Corporation · 2012 · cites it directly1descendant
- K131013Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring SystemNova Biomedical Corporation · 2013 · 2 generations on0descendants
- K122688Nova Max Mini Blood Glucose and B-Ketone MonitorNova Biomedical Corporation · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −8 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −7 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −6 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −5 | K982303 | Precision PCX Point of Care Management System , QC Manager Data Manager… | Medisense, Inc. | 1998 | — |
| −4 | K022941 | Medisense Precision PCX Point of Care Management System for Blood Glucose… | Abbott Laboratories | 2002 | — |
| −3 | K050500 | Freestyle 600 Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2005 | — |
| −2 | K051839 | Free-Style Freedom Blood Glucose Monitoring System, Model 11001 | Abbott Diabetes Care, Inc. | 2006 | 2 |
| −1 | K092638 | Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21… | Abbott Diabetes Care, Inc. | 2010 | Class I |
| 0 (this device) | K112638 | Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test Strips | Nova Biomedical Corporation | 2012 | — |
| +1 | K122435 | Nova One Blood Glucose Monitor | Nova Biomedical Corporation | 2012 | — |
| +2 | K131013 | Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring System | Nova Biomedical Corporation | 2013 | — |
| +1 | K122688 | Nova Max Mini Blood Glucose and B-Ketone Monitor | Nova Biomedical Corporation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 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? (3)
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 2…are manufactured by Nova Biomedical and Identical to those cleared for market with the predicate Nova Max Blood Glucose Monitor System (K070255). Intended Use: The Nova Max One Blood Glucose Monitor is intended to be used for the quantitative measuremen… | 2007 |
| * | K051839 | Free-Style Freedom Blood Glucose Monitoring System, Model 11001Summary page 1…t, Blood Glucose, Over the Counter Name: Product Codes: NB3W, LFR, JJX Predicate Device: K(070255 - Nova Max Blood Glucose Monitor System K(051839 - FreeStyle Freedom Blood Glucose Monitoring System K(092638 - FreeStyle Blood Glucose Test Shrips Device… | 2006 |
| * | K092638 | Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22…Summary page 1…edicate Device: K(070255 - Nova Max Blood Glucose Monitor System K(051839 - FreeStyle Freedom Blood Glucose Monitoring System K(092638 - FreeStyle Blood Glucose Test Shrips Device Nova Max One Blood Glucose Monitor Description: The monitor is… | 2010 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K092638Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22, 12101-23Abbott Diabetes Care, Inc. · 2010 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 30 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K122435 (Nova Biomedical Corporation, 2012) has gone furthest, with 1 descendant 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. 2012, 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 One Blood Glucose Monitor is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. Itis intended for single-patient home use and should not be used for testing multiple patients. It is intended for self testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes contmol. The Nova Max One Blood Glucose Monitor is specifically indicated for the…
Read the full statement (297 words)
The Nova Max One Blood Glucose Monitor is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. Itis intended for single-patient home use and should not be used for testing multiple patients. It is intended for self testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes contmol. The Nova Max One Blood Glucose Monitor is specifically indicated for the quantitative measurement of glucose in fresh whore blood capillary samples obtained from the fingertip or alternative site testing (AST) on the forearm. AST on the forearm can be used only during steady-state blood glucose conditions. It is not intended for the diagnosis of or screening for diabetes. and it is not intended for use on newborns.
Nova Max One Glucose Test Strips are intended for use only with the Nova Max One Blood Glucose Monitor for quantitative tests. The Glucose Monitor isintended to quantitatively measure glucose (sugar) in fresh capillary whole blood obtained from the finger tip or alternative site testing (AST) on the forearm. AST can be used only during steady-state blood glucose conditions. The Glucose Monitor is calibrated to provide plasma equivalent results to laboratory methods. Nova Max One Glucose Test Strips are for testing outside the body (invitro diagnostic use only). The Monitor should only be used by a single user in the home and should not be shared by users. It is not intended for the diagnosis of or screening for diabetes, and it is not. intended for use on newborns.
Nova Max Control Solutions are intended for use with the Nova Max Blood Glucose Monitoring Systems as a quality control check to verify the accuracy of blood glucose test results. There are three levels of controls, (Levels 1,2,3).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112638 · printed Nov 5, 2026
Cite this page
510(k) Report. “K112638: Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K112638
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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