510(k) · Cleared
Recalled · 2006Accu-Chek Comfort Curve Test Strip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · LFR Glucose Dehydrogenase, Glucose
Cleared on Mar 7, 2001 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 65 devices in its family, counting itself, has a Class I recall. 64 later devices descend from it. It has been recalled 6 times.
- Decided
- Mar 7, 2001
- Review
- 29 days
- Class
- Class II
- Product code
- LFR
- Recalls
- 6
- Predicates
- 0
64 later devices descend from it, 1 citing it directly. 1 of the 65 devices in this family, counting this one, has a Class I recall.
- This deviceK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001
- Descendant · cites it directly · 63 of its ownK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- Descendant · 2 generations on · 46 of its ownK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
- Descendant · 2 generations on · 44 of its ownK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
- Descendant · 3 generations on · 37 of its ownK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- Descendant · 4 generations on · 33 of its ownK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · Recalled
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193483 Basal-IQ Technology8 generations on · 2020
Most influential descendants
Showing 5 of 64 · See all- K043474Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · cites it directly63descendants
- K060620Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · 2 generations on46descendants
- K101299Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011 · 2 generations on44descendants
- K111353Accu-Check Combo SystemRoche Diagnostics · 2012 · 3 generations on37descendants
- K141929Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · 4 generations on33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | — |
| +1 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| +2 | K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics Corp. | 2006 | 1 |
| +2 | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | Roche Diagnostics | 2011 | — |
| +3 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| +4 | K141929 | Accu-Chek Connect Diabetes Management App | Roche Diagnostics Corporation | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2020 | 5 | 1 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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.
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.
- 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? (64)
See all 641 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043474 | Accu-Chek Aviva System | 2005 | 63 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 27, 2006 | Not classified | Z-1377-06 | Other | The drying agent beads, located in the cap, may become loose and fall into the vial causing the test strips to potentially give incorrect blood glucose test results. |
| Feb 10, 2006 | Not classified | Z-0571-06 | Other | There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings. |
| Feb 10, 2006 | Not classified | Z-0572-06 | Other | There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings. |
| Feb 10, 2006 | Not classified | Z-0573-06 | Other | There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings.. |
| Feb 10, 2006 | Not classified | Z-0566-06 | Other | There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings. |
| 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. |
The 5 latest of 6 recalls; the web page lists all.
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.
- K193483Basal-IQ TechnologyTandem Diabetes Care, Inc. · 2020 · 8 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K043474 (Roche Diagnostics Corp., 2005) has gone furthest, with 63 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/K010362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010362: Accu-Chek Comfort Curve Test Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010362
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026