510(k) · Cleared
Recalled · 2009Free-Style Freedom Blood Glucose Monitoring System, Model 11001
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 Mar 9, 2006 as substantially equivalent to K992684 (Abbott Diabetes Care, Inc., 2000) and 4 other predicates after a 245-day review. Its family tree reaches back 7 generations to 1995. 2 of the 38 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 9, 2006
- Review
- 245 days
- Class
- Class II
- Product code
- NBW
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 7 generations to K945887 (1995). 27 ancestors in all, the oldest K896951 (1990). 10 later devices descend from it, 3 citing it directly. 2 of the 38 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 6 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 5 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 4 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 3 generations backK982303 Precision PCX Point of Care Management System , QC Manager Data…Medisense, Inc. · 1998
- 2 generations backK022941 Medisense Precision PCX Point of Care Management System for Blood…Abbott Laboratories · 2002
- 1 generation backK050500 Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2005
- This deviceK051839 Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc. · 2006
- 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 · cites it directly · 4 of its ownK070850 Freestyle Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2007 · Recalled
- 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 · 2 of its ownK092602 FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom…Abbott Diabetes Care, Inc. · 2010 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK122435 Nova One Blood Glucose MonitorNova Biomedical Corporation · 2012
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 10 · See all- 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 · cites it directly4descendants
- K112638Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test StripsNova Biomedical Corporation · 2012 · cites it directly3descendants
- K092602FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose…Abbott Diabetes Care, Inc. · 2010 · 2 generations on2descendants
- K122435Nova One Blood Glucose MonitorNova Biomedical Corporation · 2012 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −6 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −5 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −4 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −3 | K982303 | Precision PCX Point of Care Management System , QC Manager Data Manager… | Medisense, Inc. | 1998 | — |
| −2 | K022941 | Medisense Precision PCX Point of Care Management System for Blood Glucose… | Abbott Laboratories | 2002 | — |
| −1 | K050500 | Freestyle 600 Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2005 | — |
| 0 (this device) | K051839 | Free-Style Freedom Blood Glucose Monitoring System, Model 11001 | Abbott Diabetes Care, Inc. | 2006 | — |
| +1 | K092638 | Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21… | Abbott Diabetes Care, Inc. | 2010 | Class I |
| +1 | K070850 | Freestyle Lite Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2007 | 1 |
| +1 | K112638 | Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test Strips | Nova Biomedical Corporation | 2012 | — |
| +2 | K092602 | FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite… | Abbott Diabetes Care, Inc. | 2010 | Class I |
| +2 | K122435 | Nova One Blood Glucose Monitor | Nova Biomedical Corporation | 2012 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 2 |
| 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? (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 2…Predicate Device Subject (modified) Device Company Abbott Diabetes Care Inc Same K992684, K000582, K012014, Current Submission 510(k) Reference K031260, K050500… | 2000 |
| * | K000582 | Freestyle Blood Glucose Monitoring System, Cat NO 11001Summary page 2…redicate Device Subject (modified) Device Company Abbott Diabetes Care Inc Same K992684, K000582, K012014, Current Submission 510(k) Reference K031260, K050500 FreeSt… | 2000 |
| * | K012014 | Modification to Blood Glucose Monitoring SystemSummary page 2…Device Subject (modified) Device Company Abbott Diabetes Care Inc Same K992684, K000582, K012014, Current Submission 510(k) Reference K031260, K050500 FreeStyle Blood… | 2001 |
| * | K031260 | Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System…Summary page 2…Abbott Diabetes Care Inc Same K992684, K000582, K012014, Current Submission 510(k) Reference K031260, K050500 FreeStyle Blood Glucose FreeStyle FreedomTM Blood Proprietary Name:… | 2003 |
| * | K050500 | Freestyle 600 Blood Glucose Monitoring SystemSummary page 2…Diabetes Care Inc Same K992684, K000582, K012014, Current Submission 510(k) Reference K031260, K050500 FreeStyle Blood Glucose FreeStyle FreedomTM Blood Proprietary Name: Monit… | 2005 |
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 13, 2009 | Not classified | Z-1258-2011 | Other | Product dispositioned for destruction was potentially diverted to end users. |
| May 22, 2006 | Not classified | Z-1307-06 | Other | The products may encounter display problem, 'Er 4' message, during prolonged use when the low battery symbol is displayed. The situation can render the meter either inoperable or operable with invalid user configuration data including… |
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 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 27 ancestors have a recall of any class.
- Of its descendants, K092638 (Abbott Diabetes Care, Inc., 2010) has gone furthest, with 4 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?
The FreeStyle FreedomTM Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand.
The FreeStyle FreedomTM 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 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/K051839 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051839: Free-Style Freedom Blood Glucose Monitoring System, Model 11001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051839
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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