510(k) · Cleared
Recalled · Class I · 2014Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22, 12101-23
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Diabetes Care, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jun 15, 2010 as substantially equivalent to K992684 (Abbott Diabetes Care, Inc., 2000) and 4 other predicates after a 292-day review. Its family tree reaches back 8 generations to 1995. 1 of the 33 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Jun 15, 2010
- Review
- 292 days
- Class
- Class II
- Product code
- NBW
- Recalls
- 2 (2 Class I)
- Predicates
- 5
Its longest line of descent runs back 8 generations to K945887 (1995). 28 ancestors in all, the oldest K896951 (1990). 4 later devices descend from it, 1 citing it directly. 1 of the 33 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 7 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 6 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 5 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 4 generations backK982303 Precision PCX Point of Care Management System , QC Manager Data…Medisense, Inc. · 1998
- 3 generations backK022941 Medisense Precision PCX Point of Care Management System for Blood…Abbott Laboratories · 2002
- 2 generations backK050500 Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2005
- 1 generation backK051839 Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc. · 2006 · Recalled
- This deviceK092638 Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01…Abbott Diabetes Care, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK112638 Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test…Nova Biomedical Corporation · 2012
- Descendant · 2 generations on · 1 of its ownK122435 Nova One Blood Glucose MonitorNova Biomedical Corporation · 2012
- Descendant · 3 generations on · 0 of its ownK131013 Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose…Nova Biomedical Corporation · 2013
- Descendant · 2 generations on · 0 of its ownK122688 Nova Max Mini Blood Glucose and B-Ketone MonitorNova Biomedical Corporation · 2013
Most influential descendants
Showing 4 of 4 · See all- K112638Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test StripsNova Biomedical Corporation · 2012 · cites it directly3descendants
- K122435Nova One Blood Glucose MonitorNova Biomedical Corporation · 2012 · 2 generations on1descendant
- K131013Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring SystemNova Biomedical Corporation · 2013 · 3 generations on0descendants
- K122688Nova Max Mini Blood Glucose and B-Ketone MonitorNova Biomedical Corporation · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −7 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −6 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −5 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −4 | K982303 | Precision PCX Point of Care Management System , QC Manager Data Manager… | Medisense, Inc. | 1998 | — |
| −3 | K022941 | Medisense Precision PCX Point of Care Management System for Blood Glucose… | Abbott Laboratories | 2002 | — |
| −2 | K050500 | Freestyle 600 Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2005 | — |
| −1 | K051839 | Free-Style Freedom Blood Glucose Monitoring System, Model 11001 | Abbott Diabetes Care, Inc. | 2006 | 2 |
| 0 (this device) | K092638 | Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21… | Abbott Diabetes Care, Inc. | 2010 | — |
| +1 | K112638 | Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test Strips | Nova Biomedical Corporation | 2012 | — |
| +2 | K122435 | Nova One Blood Glucose Monitor | Nova Biomedical Corporation | 2012 | — |
| +3 | K131013 | Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring System | Nova Biomedical Corporation | 2013 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K992684 | Freestyle Blood Glucose Monitoring SystemSummary page 1…~Single Analyte Control Solution, Class 1(21 CFR§ 862.1660) Product code: JJX FreeStyle Blood Glucose Monitoring System (K992684, K000582, K012014, Predicae: and K03 1260), and FreeStyle Freedom Blood Glucose Monitoring System Device:… | 2000 |
| * | K000582 | Freestyle Blood Glucose Monitoring System, Cat NO 11001Summary page 1…ngle Analyte Control Solution, Class 1(21 CFR§ 862.1660) Product code: JJX FreeStyle Blood Glucose Monitoring System (K992684, K000582, K012014, Predicae: and K03 1260), and FreeStyle Freedom Blood Glucose Monitoring System Device: (K051839… | 2000 |
| * | K012014 | Modification to Blood Glucose Monitoring SystemSummary page 1…yte Control Solution, Class 1(21 CFR§ 862.1660) Product code: JJX FreeStyle Blood Glucose Monitoring System (K992684, K000582, K012014, Predicae: and K03 1260), and FreeStyle Freedom Blood Glucose Monitoring System Device: (K051839)… | 2001 |
| * | K031260 | Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System…Summary page 1…FR§ 862.1660) Product code: JJX FreeStyle Blood Glucose Monitoring System (K992684, K000582, K012014, Predicae: and K03 1260), and FreeStyle Freedom Blood Glucose Monitoring System Device: (K051839) Establishment.… | 2003 |
| * | K051839 | Free-Style Freedom Blood Glucose Monitoring System, Model 11001Summary page 1…ood Glucose Monitoring System (K992684, K000582, K012014, Predicae: and K03 1260), and FreeStyle Freedom Blood Glucose Monitoring System Device: (K051839) Establishment. Abbott Diabetes Care Inc. 1360 South Loop Rd.… | 2006 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112638 | Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test Strips | 2012 | 3 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 19, 2014 | Class I | Z-1212-2014 | Material/Component Contamination | Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results… |
| Feb 19, 2014 | Class I | Z-1211-2014 | Material/Component Contamination | Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results… |
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 1.3 years on median.
- 6 of the 28 ancestors have a recall of any class.
- Of its descendants, K112638 (Nova Biomedical Corporation, 2012) has gone furthest, with 3 descendants of its own.
- 7 other devices also cite its predicate K992684.
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 FreeStyle 3 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates…
Read the full statement (320 words)
The FreeStyle 3 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
The FreeStyle 5 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
The FreeStyle Flash Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
The FreeStyle Freedom Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092638 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092638: Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22, 12101-23.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092638
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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