510(k) · Cleared
ClearedNova One Blood Glucose 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 Dec 20, 2012 as substantially equivalent to K112638 (Nova Biomedical Corporation, 2012) and 1 other predicate after a 132-day review. Its family tree reaches back 10 generations to 1995. 1 of the 34 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Dec 20, 2012
- Review
- 132 days
- Class
- Class II
- Product code
- LFR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K945887 (1995). 32 ancestors in all, the oldest K896951 (1990). 1 later device descends from it, 1 citing it directly. 1 of the 34 devices in this family, counting this one, has 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 deviceK122435 Nova One Blood Glucose MonitorNova Biomedical Corporation · 2012
- Descendant · cites it directly · 0 of its ownK131013 Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose…Nova 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 deviceK122435 Nova One Blood Glucose MonitorNova Biomedical Corporation · 2012
Class I recalls in this family
- K092638 Freestyle Blood Glucose Test Strips, Models…2 generations back · 2010
Most influential descendants
Showing 1 of 1 · See all- K131013Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring SystemNova Biomedical Corporation · 2013 · cites it directly0descendants
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) | K122435 | Nova One Blood Glucose Monitor | Nova Biomedical Corporation | 2012 | — |
| +1 | K131013 | Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring System | 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 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 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.
- 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 |
|---|---|---|---|
| * | K112638 | Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test StripsSummary page 2…controls are manufactured by Nova Biomedical and identical to those cleared for distribution with the predicate Nova Max One Blood Glucose Monitor System (K1 12638). Page 2 of 5 === Page… | 2012 |
| * | K080641 | Trueresult Blood Glucose System E4H01-81Summary page 3…quantitative measure of glucose in whole blood and control solutions. H. Predicate Device: K1 12638 - Nova Max One Blood Glucose Monitor System. K080641 - Home Diagnostics Inc. TRUIEresult Blood Glucose Monitor System L Comparison to Predicate Devices: The Nova One Blo… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131013 | Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring System | 2013 | 0 |
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 · 2 generations back · ◆ 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.
- 8 of the 32 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K131013 (Nova Biomedical Corporation, 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K112638.
How does its category compare?
All LFR devicesLFR Glucose Dehydrogenase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 One Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous, arterial and fresh capillary whole blood from the finger and forearm. It is intended for testing outside the body (invitro diagnostic use) and is intended for multiple-patient use in a professional healthcare setting as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use…
Read the full statement (256 words)
The Nova One Blood Glucose Monitoring System is intended to be used for the quantitative
measurement of glucose in venous, arterial and fresh capillary whole blood from the finger and
forearm. It is intended for testing outside the body (invitro diagnostic use) and is intended for
multiple-patient use in a professional healthcare setting as an aid to monitor the effectiveness of
diabetes control program. This system should only be used with single-use, auto-disabling
lancets. The Nova One Blood Glucose Monitoring System is not intended for the diagnosis of or
screening for diabetes, and it is not intended for use on neonates. Alternative site testing on the
forearm should be used only during steady-state blood glucose conditions.
Nova One Blood Glucose Test Strips are for use with the Nova One Blood Glucose Monitors for
quantitatively measuring glucose in venous, arterial and fresh capillary whole blood from the
finger and forearm. The Glucose Monitor is calibrated to provide plasma equivalent results to
laboratory methods. Nova One Glucose Test Strips are for testing outside the body (in vitro
diagnostic use only). The Nova One Blood Glucose Monitor should only be used as directed.
They are not intended for the diagnosis of or screening for diabetes, and are not intended for use
on newborns.
Nova Max Control Solutions are intended for use with the Nova Max, Nova Max One and Nova
One 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/K122435 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122435: Nova One Blood Glucose Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122435
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