510(k) · Cleared
Recalled · Class I · 2013Freestyle Insulinx 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. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Mar 29, 2012 as substantially equivalent to K111874 (Abbott Laboratories, 2012) after a 31-day review. Its family tree reaches back 6 generations to 1995. 1 of the 18 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled once, including a Class I recall.
- Decided
- Mar 29, 2012
- Review
- 31 days
- Class
- Class II
- Product code
- NBW
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 6 generations to K945887 (1995). 16 ancestors in all, the oldest K922888 (1992). 1 later device descends from it, 1 citing it directly. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 5 generations backK970707 Elect II Blood Glucose Monitoring SystemSelfcare, Inc. · 1997
- 4 generations backK992684 Freestyle Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2000 · Recalled
- 3 generations backK012014 Modification to Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2001
- 2 generations backK020866 Freestyle Tracker Diabetes Management SystemAbbott Diabetes Care, Inc. · 2002
- 1 generation backK111874 Freestyle Insulinx Blood Glucose Monitoring SystemsAbbott Laboratories · 2012
- This deviceK120568 Freestyle Insulinx Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK152328 FreeStyle InsuLinx Blood Glucose Monotioring SystemAbott Laboratories · 2015
Most influential descendants
Showing 1 of 1 · See all- K152328FreeStyle InsuLinx Blood Glucose Monotioring SystemAbott Laboratories · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −5 | K970707 | Elect II Blood Glucose Monitoring System | Selfcare, Inc. | 1997 | — |
| −4 | K992684 | Freestyle Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2000 | 2 |
| −3 | K012014 | Modification to Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2001 | — |
| −2 | K020866 | Freestyle Tracker Diabetes Management System | Abbott Diabetes Care, Inc. | 2002 | — |
| −1 | K111874 | Freestyle Insulinx Blood Glucose Monitoring Systems | Abbott Laboratories | 2012 | — |
| 0 (this device) | K120568 | Freestyle Insulinx Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2012 | — |
| +1 | K152328 | FreeStyle InsuLinx Blood Glucose Monotioring System | Abott Laboratories | 2015 | — |
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 |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K111874 | Freestyle Insulinx Blood Glucose Monitoring SystemsSummary page 5…Insutinx Blood Modified FreeStjle InsutLinx Glucose Monitoring System, Blood Glucose Monitoring ______________(k111874) FSystem CHARACTERISTICS Indications for Use The FreeStyle lnsuLinx Blood Same… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152328 | FreeStyle InsuLinx Blood Glucose Monotioring System | 2015 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 15, 2013 | Class I | Z-1245-2013 | Software design | AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 4 of the 16 ancestors have a recall of any class.
- Of its descendants, K152328 (Abott Laboratories, 2015) has gone furthest, with 0 descendants of its own.
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. 2012, 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 InsuL-inx Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. The FreeStyle InsuLinx Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home…
Read the full statement (134 words)
The FreeStyle InsuL-inx Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. The FreeStyle InsuLinx Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The FreeStyle InsuLinx Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use.
The FreeStyle lnsuLinx Blood Glucose Test Strips are for use with the FreeStyle lnsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120568: Freestyle Insulinx Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120568
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