510(k) · Cleared
ClearedNova Max Mini Blood Glucose and B-Ketone Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nova Biomedical Corporation · LFR Glucose Dehydrogenase, Glucose
Cleared on Apr 4, 2013 as substantially equivalent to K091547 (Nova Biomedical Corp., 2010) and 1 other predicate after a 212-day review. Its family tree reaches back 10 generations to 1995. 2 of the 37 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 4, 2013
- Review
- 212 days
- Class
- Class II
- Product code
- LFR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K945887 (1995). 36 ancestors in all, the oldest K850368 (1985). No later device cites it as a predicate yet. 2 of the 37 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 6 generations between
- 3 generations backK051839 Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc. · 2006 · Recalled
- 2 generations backK092638 Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01…Abbott Diabetes Care, Inc. · 2010 · Recalled (Class I)
- 1 generation backK112638 Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test…Nova Biomedical Corporation · 2012
- This deviceK122688 Nova Max Mini Blood Glucose and B-Ketone MonitorNova Biomedical Corporation · 2013
Show all 10 generations
- Root · 10 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 9 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 8 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 7 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 6 generations backK982303 Precision PCX Point of Care Management System , QC Manager Data…Medisense, Inc. · 1998
- 5 generations backK022941 Medisense Precision PCX Point of Care Management System for Blood…Abbott Laboratories · 2002
- 4 generations backK050500 Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2005
- 3 generations backK051839 Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc. · 2006 · Recalled
- 2 generations backK092638 Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01…Abbott Diabetes Care, Inc. · 2010 · Recalled (Class I)
- 1 generation backK112638 Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test…Nova Biomedical Corporation · 2012
- This deviceK122688 Nova Max Mini Blood Glucose and B-Ketone MonitorNova Biomedical Corporation · 2013
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −9 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −8 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −7 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −6 | K982303 | Precision PCX Point of Care Management System , QC Manager Data Manager… | Medisense, Inc. | 1998 | — |
| −5 | K022941 | Medisense Precision PCX Point of Care Management System for Blood Glucose… | Abbott Laboratories | 2002 | — |
| −4 | K050500 | Freestyle 600 Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2005 | — |
| −3 | K051839 | Free-Style Freedom Blood Glucose Monitoring System, Model 11001 | Abbott Diabetes Care, Inc. | 2006 | 2 |
| −2 | K092638 | Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21… | Abbott Diabetes Care, Inc. | 2010 | Class I |
| −1 | K112638 | Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test Strips | Nova Biomedical Corporation | 2012 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 1 |
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.
2 devices in this family have a Class I recall. 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? (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 |
|---|---|---|---|
| * | K091547 | Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control…Summary page 2…ckaged in foil pouches. The ketone test strip is identical to the strip cleared for market with the predicate Nova Max Plus Blood Glucose and P-Ketone Monitor (K091 547). Control Solutions The control solutions are aqueous assayed solutions, containing buffered D-Glucose,… | 2010 |
| * | K112638 | Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test StripsSummary page 2…. These test strips are manufactured by Nova Biomedical and identical to those cleared for market with the predicate Nova Max One Blood Glucose Monitor System (K1 12638). Nova Max Mini 1-Ketone Test Strips The Nova Max Mini 1-Ketone test strips contain a reaction layer that contains the… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 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.
- K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max…Nova Biomedical Corp. · 2010 · Direct predicate · ◆ in the 2010 ancestors bar of FIG. 110 Class I recalls
- K092638Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22, 12101-23Abbott Diabetes Care, Inc. · 2010 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 10 of the 36 ancestors have a recall of any class; 2 have a Class I recall.
- 6 other devices also cite its predicate K091547.
How does its category compare?
All LFR devicesLFR Glucose Dehydrogenase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LFR
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · LFR
161in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFR
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFR
827in 2025
MAUDE reports naming product code LFR, 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 | 23,819 |
| 2008 | 0 | — | 1 | 6,584 |
| 2009 | 1 | — | 4 | 10,823 |
| 2010 | 0 | — | 0 | 4,865 |
| 2011 | 6 | 296 | 1 | 3,802 |
| 2012 | 13 | 152 | 1 | 3,341 |
| 2013 | 3 | 212 | 0 | 3,821 |
| 2014 | 3 | 161 | 0 | 3,960 |
| 2015 | 1 | — | 0 | 3,366 |
| 2016 | 0 | — | 0 | 2,145 |
| 2017 | 0 | — | 0 | 103 |
| 2018 | 0 | — | 0 | 108 |
| 2019 | 0 | — | 0 | 108 |
| 2020 | 0 | — | 0 | 132 |
| 2021 | 0 | — | 0 | 164 |
| 2022 | 0 | — | 0 | 101 |
| 2023 | 0 | — | 0 | 103 |
| 2024 | 0 | — | 0 | 171 |
| 2025 | 0 | — | 0 | 827 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Nova Max Mini Blood Glucose and 1-Ketone Monitor System is intended to be used for the quantitative measurement of glucose or 3-hydroxybutyrate (j3-ketone) in fresh capillary whole blood. It is 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 control. The Nova Max Mini Blood…
Read the full statement (259 words)
The Nova Max Mini Blood Glucose and 1-Ketone Monitor System is intended to be used for the quantitative measurement of glucose or 3-hydroxybutyrate (j3-ketone) in fresh capillary whole blood. It is 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 control. The Nova Max Mini Blood Glucose and j3-Ketone Monitor System is specifically indicated for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip or alternative site testing on the forearm, or 03-ketone in whole blood capillary samples obtained from the fingertip only. Glucose AST on the forearm can be used only during steady-state blood glucose conditions.
The Nova Max Mini is not intended for the diagnosis of or screening for diabetes, and it is not intended for use on neonates.
The Nova Max Mini Blood Glucose Test Strips are intended for use only with the Nova Max Mini Blood Glucose Monitor System to quantitatively measure capillary blood glucose from the finger and forearm.
The Nova Max Mini Ketone Test Strips are intended for use only on the Nova Max Mini Blood Glucose and P-Ketone Monitor System to quantitatively measure capillary j3-hydroxybutyrate from the finger.
Nova Max Mini Glucose/Ketone Control Solutions are intended for use with the Max Mini Glucose or P-Ketone Test Strips as a quality control check to verify the accuracy of test results. There are two levels of controls, (Level 2 and Level 3).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122688: Nova Max Mini Blood Glucose and B-Ketone Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122688
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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