510(k) · Cleared
Recalled · 2008Freestyle Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Diabetes Care, Inc. · LFR Glucose Dehydrogenase, Glucose
Cleared on Jan 14, 2000 as substantially equivalent to K970707 (Selfcare, Inc., 1997) and 4 other predicates after a 157-day review. Its family tree reaches back 2 generations to 1995. 3 of the 43 devices in its family, counting itself, have a Class I recall. 33 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 14, 2000
- Review
- 157 days
- Class
- Class II
- Product code
- LFR
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 2 generations to K945887 (1995). 9 ancestors in all, the oldest K922888 (1992). 33 later devices descend from it, 8 citing it directly. 3 of the 43 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 1 generation backK970707 Elect II Blood Glucose Monitoring SystemSelfcare, Inc. · 1997
- This deviceK992684 Freestyle Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2000
- Descendant · cites it directly · 23 of its ownK012014 Modification to Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2001
- Descendant · cites it directly · 22 of its ownK020866 Freestyle Tracker Diabetes Management SystemAbbott Diabetes Care, Inc. · 2002
- Descendant · cites it directly · 18 of its ownK031260 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
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 33 · See all- K012014Modification to Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2001 · cites it directly23descendants
- K020866Freestyle Tracker Diabetes Management SystemAbbott Diabetes Care, Inc. · 2002 · cites it directly22descendants
- K031260Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System…Abbott Diabetes Care, Inc. · 2003 · cites it directly18descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −1 | K970707 | Elect II Blood Glucose Monitoring System | Selfcare, Inc. | 1997 | — |
| 0 (this device) | K992684 | Freestyle Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2000 | — |
| +1 | K012014 | Modification to Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2001 | — |
| +1 | K020866 | Freestyle Tracker Diabetes Management System | Abbott Diabetes Care, Inc. | 2002 | — |
| +1 | 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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 2 |
| 2011 | 1 | 0 |
| 2012 | 4 | 1 |
| 2013 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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.
3 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K970707 | Elect II Blood Glucose Monitoring SystemSummary page 1…rietary Names: FreeStyle™Blood Glucose Monitoring System 2. Legally Marketed Devices to which Substantial Equivalence is Claimed: Predicate Device 510(k) number FastTake K970707 Accu-Chek Advantage with Comfort Curve Test K930979 Strips K980731 K982002 AtLast K982076 3. Device Description The FreeStyle B… | 1997 |
| * | K930979 | Accu-Chek Advantage Blood Glucose SystemSummary page 1…stem 2. Legally Marketed Devices to which Substantial Equivalence is Claimed: Predicate Device 510(k) number FastTake K970707 Accu-Chek Advantage with Comfort Curve Test K930979 Strips K980731 K982002 AtLast K982076 3. Device Description The FreeStyle Blood Glucose Monitoring System comprises an electroc… | 1993 |
| * | K980731 | Accu-Chek Comfort Curve Test StripsSummary page 1…Marketed Devices to which Substantial Equivalence is Claimed: Predicate Device 510(k) number FastTake K970707 Accu-Chek Advantage with Comfort Curve Test K930979 Strips K980731 K982002 AtLast K982076 3. Device Description The FreeStyle Blood Glucose Monitoring System comprises an electrochemical biosens… | 1998 |
| * | K982002 | Accu-Chek Comfort Curve Test StripSummary page 1…d Devices to which Substantial Equivalence is Claimed: Predicate Device 510(k) number FastTake K970707 Accu-Chek Advantage with Comfort Curve Test K930979 Strips K980731 K982002 AtLast K982076 3. Device Description The FreeStyle Blood Glucose Monitoring System comprises an electrochemical biosensor gluc… | 1998 |
| * | K982076 | Amira Medical Atlast Blood Glucose Monitoring SystemSummary page 1…ich Substantial Equivalence is Claimed: Predicate Device 510(k) number FastTake K970707 Accu-Chek Advantage with Comfort Curve Test K930979 Strips K980731 K982002 AtLast K982076 3. Device Description The FreeStyle Blood Glucose Monitoring System comprises an electrochemical biosensor glucose reagent tes… | 1998 |
What descends from it? (33)
See all 338 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012014 | Modification to Blood Glucose Monitoring System | 2001 | 23 |
| K020866 | Freestyle Tracker Diabetes Management System | 2002 | 22 |
| K031260 | Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System… | 2003 | 18 |
| K050500 | Freestyle 600 Blood Glucose Monitoring System | 2005 | 12 |
| K051839 | Free-Style Freedom Blood Glucose Monitoring System, Model 11001 | 2006 | 10 |
| K012324 | Accu-Chek Active Test System | 2001 | 7 |
| K092638 | Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22… Class I | 2010 | 4 |
| K012975 | Sof-Tact Diabetes Management Sysyem; Sof-Tact Blood Glucose Test Strip; Precision… | 2002 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 24, 2008 | Not classified | Z-1813-2008 | Process control | Flaws in strip voltage continuity may result in frequency of an Error 3 ("Er3") message display and unreadable strips. This issue has the potential for creating a delay in generating blood glucose results and to delay diabetes management… |
| 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 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K120568Freestyle Insulinx Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K012014 (Abbott Diabetes Care, Inc., 2001) has gone furthest, with 23 descendants of its own.
- 1 other device also cites its predicate K970707.
How does its category compare?
All LFR devicesLFR Glucose Dehydrogenase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 TheraSense Inc. FreeStyleTM Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh whole capillary blood. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. The FreeStyle System is intended for use outside the body (in vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates (newborns) or arterial blood.
The FreeStyle Blood Glucose Monitoring System is specifically indicated for use on the finger or arm.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992684 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992684: Freestyle Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992684
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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