510(k) · Cleared
ClearedFreestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System, Models 11001, 16000, and 16005
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 Dec 19, 2003 as substantially equivalent to K992684 (Abbott Diabetes Care, Inc., 2000) and 3 other predicates after a 242-day review. Its family tree reaches back 5 generations to 1995. 2 of the 34 devices in its family, counting itself, have a Class I recall. 18 later devices descend from it.
- Decided
- Dec 19, 2003
- Review
- 242 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K945887 (1995). 15 ancestors in all, the oldest K922888 (1992). 18 later devices descend from it, 6 citing it directly. 2 of the 34 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 4 generations backK970707 Elect II Blood Glucose Monitoring SystemSelfcare, Inc. · 1997
- 3 generations backK992684 Freestyle Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2000 · Recalled
- 2 generations backK012014 Modification to Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2001
- 1 generation backK020866 Freestyle Tracker Diabetes Management SystemAbbott Diabetes Care, Inc. · 2002
- This deviceK031260 Freestyle Blood Glucose Monitoring System, Freestyle Tracker…Abbott Diabetes Care, Inc. · 2003
- Descendant · cites it directly · 12 of its ownK050500 Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2005
- Descendant · cites it directly · 10 of its ownK051839 Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc. · 2006 · Recalled
- Descendant · cites it directly · 4 of its ownK092638 Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01…Abbott Diabetes Care, Inc. · 2010 · Recalled (Class I)
- Descendant · 2 generations on · 4 of its ownK070850 Freestyle Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2007 · Recalled
- Descendant · cites it directly · 4 of its ownK060481 Liberty Glucose Control SolutionLiberty Healthcare Group, Inc. · 2006
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 18 · See all- K050500Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2005 · cites it directly12descendants
- K051839Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc. · 2006 · cites it directly10descendants
- K092638Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22…Abbott Diabetes Care, Inc. · 2010 · cites it directly4descendants
- K070850Freestyle Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2007 · 2 generations on4descendants
- K060481Liberty Glucose Control SolutionLiberty Healthcare Group, Inc. · 2006 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −4 | K970707 | Elect II Blood Glucose Monitoring System | Selfcare, Inc. | 1997 | — |
| −3 | K992684 | Freestyle Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2000 | 2 |
| −2 | K012014 | Modification to Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2001 | — |
| −1 | K020866 | Freestyle Tracker Diabetes Management System | Abbott Diabetes Care, Inc. | 2002 | — |
| 0 (this device) | K031260 | Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes… | Abbott Diabetes Care, Inc. | 2003 | — |
| +1 | 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 |
| +1 | K092638 | Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21… | Abbott Diabetes Care, Inc. | 2010 | Class I |
| +2 | K070850 | Freestyle Lite Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2007 | 1 |
| +1 | K060481 | Liberty Glucose Control Solution | Liberty Healthcare Group, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 3 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 2 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 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.
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.
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? (4)
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…ce 510(k) Number Freestyle' m Blood Glucose Monitoring System K992684 K000582… | 2000 |
| * | K000582 | Freestyle Blood Glucose Monitoring System, Cat NO 11001Summary page 1…ucose Monitoring System K992684 K000582 K012014 FreeStyle Tracker… | 2000 |
| * | K012014 | Modification to Blood Glucose Monitoring SystemSummary page 1…K000582 K012014 FreeStyle Tracker Diabetes Management System K020866 3. Device Descripti… | 2001 |
| * | K020866 | Freestyle Tracker Diabetes Management SystemSummary page 1…K012014 FreeStyle Tracker Diabetes Management System K020866 3. Device Description The FreeStyle Blood Glucose Monitoring System comprises an electrochemical biosensor glucose reagent… | 2002 |
What descends from it? (18)
See all 186 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050500 | Freestyle 600 Blood Glucose Monitoring System | 2005 | 12 |
| K051839 | Free-Style Freedom Blood Glucose Monitoring System, Model 11001 | 2006 | 10 |
| K092638 | Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22… Class I | 2010 | 4 |
| K060481 | Liberty Glucose Control Solution | 2006 | 4 |
| K083549 | Abt Glucose Control Solution | 2008 | 2 |
| K071433 | SMS Glucose Control, Model 2120059 | 2007 | 0 |
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.
- K092638Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22, 12101-23Abbott Diabetes Care, Inc. · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K092602FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 15 ancestors have a recall of any class.
- Of its descendants, K050500 (Abbott Diabetes Care, Inc., 2005) has gone furthest, with 12 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.
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?
FreeStyle Blood Glucose Monitoring System The TheraSense, Inc., FreeStyle Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on…
Read the full statement (214 words)
FreeStyle Blood Glucose Monitoring System
The TheraSense, Inc., FreeStyle Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
FreeStyle Tracker Diabetes Management System
The TheraSense, Inc., FreeStyle Tracker Diabetes Management System is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Additionally, the TheraSense, Inc. FreeStyle Tracker Diabetes Management System is intended for use in home and clinical setting to aid people with diabetes and healthcare professionals in the review, analysis, and evaluation of historical blood glucose test results to support an effective diabetes management program.
The TheraSense, Inc. FreeStyle Tracker Diabetes Management System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031260 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031260: Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System, Models 11001, 16000, and 16005.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031260
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