510(k) · Cleared
ClearedLiberty Glucose Control Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Liberty Healthcare Group, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Mar 9, 2006 as substantially equivalent to K031260 (Abbott Diabetes Care, Inc., 2003) and 1 other predicate after a 14-day review. Its family tree reaches back 6 generations to 1995. 4 later devices descend from it.
- Decided
- Mar 9, 2006
- Review
- 14 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K945887 (1995). 27 ancestors in all, the oldest K850368 (1985). 4 later devices descend from it, 2 citing it directly.
- 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 backK031260 Freestyle Blood Glucose Monitoring System, Freestyle Tracker…Abbott Diabetes Care, Inc. · 2003
- This deviceK060481 Liberty Glucose Control SolutionLiberty Healthcare Group, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK083549 Abt Glucose Control SolutionAmerican Biological Technologies, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK102260 Fdi Glucose Control SolutionsFujirebio Diagnostics,Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK103450 Fdi Glucose Control Solution for FreestyleFujirebio Diagnostics,Inc. · 2011
- Descendant · cites it directly · 0 of its ownK071433 SMS Glucose Control, Model 2120059Specialty Medical Supplies · 2007
Most influential descendants
Showing 4 of 4 · See all- K083549Abt Glucose Control SolutionAmerican Biological Technologies, Inc. · 2008 · cites it directly2descendants
- K102260Fdi Glucose Control SolutionsFujirebio Diagnostics,Inc. · 2010 · 2 generations on1descendant
- K103450Fdi Glucose Control Solution for FreestyleFujirebio Diagnostics,Inc. · 2011 · 3 generations on0descendants
- K071433SMS Glucose Control, Model 2120059Specialty Medical Supplies · 2007 · 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 | K031260 | Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes… | Abbott Diabetes Care, Inc. | 2003 | — |
| 0 (this device) | K060481 | Liberty Glucose Control Solution | Liberty Healthcare Group, Inc. | 2006 | — |
| +1 | K083549 | Abt Glucose Control Solution | American Biological Technologies, Inc. | 2008 | — |
| +2 | K102260 | Fdi Glucose Control Solutions | Fujirebio Diagnostics,Inc. | 2010 | — |
| +3 | K103450 | Fdi Glucose Control Solution for Freestyle | Fujirebio Diagnostics,Inc. | 2011 | — |
| +1 | K071433 | SMS Glucose Control, Model 2120059 | Specialty Medical Supplies | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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.
Planning a device in JJX? 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? (2)
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 |
|---|---|---|---|
| * | K031260 | Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System…Summary page 1…TheraSense FreeStyle Control Manufacturer: TheraSense, Inc. 510(k) No.: K031260 Name: Liberty Glucose Control Manufacturer:… | 2003 |
| * | K052980 | Liberty Glucose Control, Model 2120031Summary page 1…iberty Glucose Control Manufacturer: Liberty Healthcare Group, Inc. 510(k) No.: K052980 Page 12 of 38 510(k) Premarket Notification: Liberty Glucose Control A… | 2005 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 5 of the 27 ancestors have a recall of any class.
- Of its descendants, K083549 (American Biological Technologies, Inc., 2008) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K031260.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the
TheraSense FreeStyle Blood Glucose System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060481: Liberty Glucose Control Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060481
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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