510(k) · Cleared
ClearedFocus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring System
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 Oct 17, 2013 as substantially equivalent to K122435 (Nova Biomedical Corporation, 2012) after a 189-day review. Its family tree reaches back 11 generations to 1995. 1 of the 34 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 17, 2013
- Review
- 189 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K945887 (1995). 33 ancestors in all, the oldest K896951 (1990). No later device cites it as a predicate yet. 1 of the 34 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 7 generations between
- 3 generations backK092638 Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01…Abbott Diabetes Care, Inc. · 2010 · Recalled (Class I)
- 2 generations backK112638 Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test…Nova Biomedical Corporation · 2012
- 1 generation backK122435 Nova One Blood Glucose MonitorNova Biomedical Corporation · 2012
- This deviceK131013 Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose…Nova Biomedical Corporation · 2013
Show all 11 generations
- Root · 11 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 10 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 9 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 8 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 7 generations backK982303 Precision PCX Point of Care Management System , QC Manager Data…Medisense, Inc. · 1998
- 6 generations backK022941 Medisense Precision PCX Point of Care Management System for Blood…Abbott Laboratories · 2002
- 5 generations backK050500 Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2005
- 4 generations backK051839 Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc. · 2006 · Recalled
- 3 generations backK092638 Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01…Abbott Diabetes Care, Inc. · 2010 · Recalled (Class I)
- 2 generations backK112638 Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test…Nova Biomedical Corporation · 2012
- 1 generation backK122435 Nova One Blood Glucose MonitorNova Biomedical Corporation · 2012
- This deviceK131013 Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose…Nova Biomedical Corporation · 2013
Class I recalls in this family
- K092638 Freestyle Blood Glucose Test Strips, Models…3 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −10 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −9 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −8 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −7 | K982303 | Precision PCX Point of Care Management System , QC Manager Data Manager… | Medisense, Inc. | 1998 | — |
| −6 | K022941 | Medisense Precision PCX Point of Care Management System for Blood Glucose… | Abbott Laboratories | 2002 | — |
| −5 | K050500 | Freestyle 600 Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2005 | — |
| −4 | K051839 | Free-Style Freedom Blood Glucose Monitoring System, Model 11001 | Abbott Diabetes Care, Inc. | 2006 | 2 |
| −3 | K092638 | Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21… | Abbott Diabetes Care, Inc. | 2010 | Class I |
| −2 | 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 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K122435 | Nova One Blood Glucose MonitorSummary page 1…ucose Dehydrogenase, Glucose Name: Device 11 Classification: Regulation 21 CFR § 862.1345 Number: Product Codes: NBW, LFR, JJX Predicate K122435: Nova Biomedical Corporation Nova One Glucose Monitor System Device(s): Intended Use: The FOCUS Blood Glucose Monitoring Sys… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 3 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.
- 8 of the 33 ancestors have a recall of any class; 1 has a Class I recall.
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. 2013, 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 FOCUS Blood Glucose Monitoring System Is Intended for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip or forearm. Intended to be used by a single patient and should not be shared. Intended for self-testing outside the body by people with diabetes meliltus as an aid to monitor the effectiveness of diabetes control. Alternative site testing on the forearm can be used only during steady-state blood…
Read the full statement (340 words)
The FOCUS Blood Glucose Monitoring System Is Intended for the quantitative measurement of glucose in
fresh capillary whole blood obtained from the fingertip or forearm. Intended to be used by a single patient
and should not be shared. Intended for self-testing outside the body by people with diabetes meliltus as
an aid to monitor the effectiveness of diabetes control. Alternative site testing on the forearm can be used
only during steady-state blood glucose conditions. Not intended for the diagnosis of or screening for
diabetes, and not intended for use on neonates.
FOCUS Blood Glucose Test Strips are used only with FOCUS Meters to quantitatively measure whole
blood glucose in fresh, human capillary whole blood taken from the fingertip or forearm.
FOCUS Control Solution is for use with FOCUS and FOCUS PRO Meters and Test Strips as a quality
control check to verify that the meter and test strip are working together properly, and that the test is
performing correctly.
The FOCUS PRO Blood Glucose Monitoring System is Intended for the quantitative measurement of
glucose in venious and arterial whole blood and in fresh capillary whole blood obtained from the fingertip
or forearm. Intended for testing outside the body (in vitro diagnostic use) for multi-patient use in a
professional healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This
system should only be used with sing-use, auto-disabling lancing devices. Aternative site testing on the
forearm should be used only during steady-state blood glucose conditions. Not intended for the
diagnosis of or screening for diabetes, and not Intended for use on neonates.
FOCUS PRO Blood Glucose Test Strips are used only with FOCUS PRO Meters for the quantitative
measurement of glucose in venious and arterial whole blood and Infresh capillary whole blood taken from
the fingertip or forearm.
FOCUS Control Solution is for use with FOCUS and FOCUS PRO Meters and Test Strips as a quality
control check to verify that the meter and test strip are working together properly, and that the test Is
performing correctly.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131013 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131013: Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131013
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