510(k) · Cleared
ClearedFreestyle Blood Glucose Monitoring System, Cat NO 11001
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 Dec 5, 2000 after a 287-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 24 devices in its family, counting itself, have a Class I recall. 23 later devices descend from it.
- Decided
- Dec 5, 2000
- Review
- 287 days
- Class
- Class II
- Product code
- LFR
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 5 citing it directly. 3 of the 24 devices in this family, counting this one, have a Class I recall.
- This deviceK000582 Freestyle Blood Glucose Monitoring System, Cat NO 11001Abbott Diabetes Care, Inc. · 2000
- 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
- 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)
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 23 · See all- 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
- K092638Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22…Abbott Diabetes Care, Inc. · 2010 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000582 | Freestyle Blood Glucose Monitoring System, Cat NO 11001 | Abbott Diabetes Care, Inc. | 2000 | — |
| +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 |
| +1 | K092638 | Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21… | Abbott Diabetes Care, Inc. | 2010 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 2 |
| 2011 | 1 | 0 |
| 2012 | 4 | 1 |
| 2013 | 2 | 0 |
| 2015 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (23)
See all 235 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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 |
| K092638 | Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22… Class I | 2010 | 4 |
Has anything in its family been recalled? (3 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
- 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?
- Of its descendants, K020866 (Abbott Diabetes Care, Inc., 2002) has gone furthest, with 22 descendants of its own.
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 | — |
https://510kreport.com/device/K000582 · printed Nov 4, 2026
Cite this page
510(k) Report. “K000582: Freestyle Blood Glucose Monitoring System, Cat NO 11001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000582
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026