510(k) · Cleared
Recalled · 2005Accu-Chek Aviva System
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 Apr 27, 2005 as substantially equivalent to K010362 (Roche Diagnostics Corp., 2001) and 1 other predicate after a 132-day review. Its family tree reaches back 1 generation to 2001. 1 of the 66 devices in its family, counting itself, has a Class I recall. 63 later devices descend from it. It has been recalled 10 times.
- Decided
- Apr 27, 2005
- Review
- 132 days
- Class
- Class II
- Product code
- LFR
- Recalls
- 10
- Predicates
- 2
Its longest line of descent runs back 1 generation to K010362 (2001). 2 ancestors in all. 63 later devices descend from it, 10 citing it directly. 1 of the 66 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- This deviceK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005
- Descendant · cites it directly · 46 of its ownK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
- Descendant · cites it directly · 44 of its ownK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
- Descendant · 2 generations on · 37 of its ownK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- Descendant · 3 generations on · 33 of its ownK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · Recalled
- Descendant · 4 generations on · 32 of its ownK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193483 Basal-IQ Technology7 generations on · 2020
Most influential descendants
Showing 5 of 63 · See all- K060620Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · cites it directly46descendants
- K101299Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011 · cites it directly44descendants
- K111353Accu-Check Combo SystemRoche Diagnostics · 2012 · 2 generations on37descendants
- K141929Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · 3 generations on33descendants
- K150910ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · 4 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| 0 (this device) | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | — |
| +1 | K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics Corp. | 2006 | 1 |
| +1 | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | Roche Diagnostics | 2011 | — |
| +2 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| +3 | K141929 | Accu-Chek Connect Diabetes Management App | Roche Diagnostics Corporation | 2015 | 1 |
| +4 | K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015 | 6 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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.
- 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 |
|---|---|---|---|
| * | K010362 | Accu-Chek Comfort Curve Test StripSummary page 1…Classification name: 75, LER, Glucose dehydrogenase, glucose 3) Predicate We claim substantial equivalence to the ACCU-CHEK Advantage system, device K010362 and K032552. 4) Device The ACCU-CHEK Aviva system utilizes reagent test strips stored within a description desiccat… | 2001 |
| * | K032552 | Accu-Chek Advantage SystemSummary page 1…ication name: 75, LER, Glucose dehydrogenase, glucose 3) Predicate We claim substantial equivalence to the ACCU-CHEK Advantage system, device K010362 and K032552. 4) Device The ACCU-CHEK Aviva system utilizes reagent test strips stored within a description desiccated vial. A t… | 2003 |
What descends from it? (63)
See all 6310 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060620 | Accu-Chek Aviva Test Strips | 2006 | 46 |
| K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | 2011 | 44 |
| K121679 | Accu-Chek Inform II Blood Glucose Monitoring System | 2012 | 5 |
| K160944 | ACCU-CHEK Guide Blood Glucose Monitoring System | 2016 | 3 |
| K081403 | Glucose Meter-Check Control Solution for Roche Accu-Chek | 2008 | 2 |
| K082965 | DS-a Blood Glucose Monitoring System | 2009 | 1 |
| K083628 | Glucodr Auto System | 2009 | 1 |
| K123612 | Fdi Glucose Control Solution for Use with Accu-Chek Aviva | 2013 | 0 |
| K110436 | Fdi Glucose Control Solution for Aviva | 2011 | 0 |
| K082328 | Glucodr Plus System, Model Agm-3000 | 2009 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 9, 2005 | Not classified | Z-0417-06 | Other | Incorrect patient blood glucose test results may be reported due to a software problem. |
| Nov 9, 2005 | Not classified | Z-0418-06 | Other | Incorrect patient blood glucose test results may be reported due to a software problem. |
| Nov 9, 2005 | Not classified | Z-0420-06 | Other | Incorrect patient blood glucose test results may be reported due to a software problem. |
| Nov 9, 2005 | Not classified | Z-0419-06 | Other | Incorrect patient blood glucose test results may be reported due to a software problem. |
| Nov 9, 2005 | Not classified | Z-0421-06 | Other | Incorrect patient blood glucose test results may be reported due to a software problem. |
| Nov 9, 2005 | Not classified | Z-0425-06 | Other | Incorrect patient blood glucose test results may be reported due to a software problem. |
| Nov 9, 2005 | Not classified | Z-0426-06 | Other | Incorrect patient blood glucose test results may be reported due to a software problem. |
| Nov 9, 2005 | Not classified | Z-0422-06 | Other | Incorrect patient blood glucose test results may be reported due to a software problem. |
| Nov 9, 2005 | Not classified | Z-0423-06 | Other | Incorrect patient blood glucose test results may be reported due to a software problem. |
| Nov 9, 2005 | Not classified | Z-0424-06 | Other | Incorrect patient blood glucose test results may be reported due to a software problem. |
The 5 latest of 10 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 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K060620 (Roche Diagnostics Corp., 2006) has gone furthest, with 46 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 | — |
What is it indicated for?
The ACCU-CHEK® Aviva system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals for monitoring blood glucose in the home or health care facility. The device is intended for professional use and over-the-counter sale. Professionals may use the test strip to test capillary and venous blood samples; lay use is limited to capillary whole blood testing. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043474 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043474: Accu-Chek Aviva System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043474
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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