510(k) · Cleared
Recalled · 2003Accu-Chek Comfort Curve Test Strip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · LFR Glucose Dehydrogenase, Glucose
Cleared on Sep 2, 1998 as substantially equivalent to K980731 (Boehringer Mannheim Corp., 1998) after an 86-day review. Its family tree reaches back 1 generation to 1998. 3 of the 51 devices in its family, counting itself, have a Class I recall. 49 later devices descend from it. It has been recalled once.
- Decided
- Sep 2, 1998
- Review
- 86 days
- Class
- Class II
- Product code
- LFR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980731 (1998). 49 later devices descend from it, 3 citing it directly. 3 of the 51 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK980731 Accu-Chek Comfort Curve Test StripsBoehringer Mannheim Corp. · 1998
- This deviceK982002 Accu-Chek Comfort Curve Test StripBoehringer Mannheim Corp. · 1998
- Descendant · cites it directly · 33 of its ownK992684 Freestyle Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2000 · Recalled
- Descendant · 2 generations on · 23 of its ownK012014 Modification to Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2001
- Descendant · 2 generations on · 22 of its ownK020866 Freestyle Tracker Diabetes Management SystemAbbott Diabetes Care, Inc. · 2002
- Descendant · 2 generations on · 18 of its ownK031260 Freestyle Blood Glucose Monitoring System, Freestyle Tracker…Abbott Diabetes Care, Inc. · 2003
- Descendant · 2 generations on · 12 of its ownK050500 Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2005
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 49 · See all- K992684Freestyle Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2000 · cites it directly33descendants
- K012014Modification to Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2001 · 2 generations on23descendants
- K020866Freestyle Tracker Diabetes Management SystemAbbott Diabetes Care, Inc. · 2002 · 2 generations on22descendants
- K031260Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System…Abbott Diabetes Care, Inc. · 2003 · 2 generations on18descendants
- K050500Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2005 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980731 | Accu-Chek Comfort Curve Test Strips | Boehringer Mannheim Corp. | 1998 | — |
| 0 (this device) | K982002 | Accu-Chek Comfort Curve Test Strip | Boehringer Mannheim Corp. | 1998 | — |
| +1 | K992684 | Freestyle Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2000 | 2 |
| +2 | K012014 | Modification to Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2001 | — |
| +2 | K020866 | Freestyle Tracker Diabetes Management System | Abbott Diabetes Care, Inc. | 2002 | — |
| +2 | K031260 | Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes… | Abbott Diabetes Care, Inc. | 2003 | — |
| +2 | K050500 | Freestyle 600 Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 2 |
| 2011 | 1 | 0 |
| 2012 | 4 | 1 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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.
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? (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 |
|---|---|---|---|
| * | K980731 | Accu-Chek Comfort Curve Test StripsSummary page 2…cts in commercial distribution intended for similar use. Most notably it is substantially equivalent to the previously 510(k) cleared Accu-Chek Comfort Curve Test Strip (k980731). Blood glucose concentrations can be expressed two ways, as whole blood glucose or as plasma (or serum) glucose. The concentrat… | 1998 |
What descends from it? (49)
See all 493 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 12, 2003 | Not classified | Z-0715-03 | Other | Crack in the bottom of the test strip vial will cause erroneously low or high blood glucose readings. |
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 · 2 generations on · ◆ 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 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K120568Freestyle Insulinx Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 Accu-Chek Comfort Curve Test Strips are to be used with the Accu-Chek® Advantage® and Accu-Chek® Complete™ Monitors. The Accu-Chek Advantage and Accu-Chek Complete systems are designed for testing glucose in whole blood by persons with diabetes or by health care professionals in the home or in health care facilities.
Professionals may use the test strips to test capillary, venous, arterial and neonate (including cord) blood samples; lay use is limited to capillary blood testing.
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/K982002 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982002: Accu-Chek Comfort Curve Test Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982002
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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