510(k) · Cleared
ClearedAccu-Chek Aviva Expert System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corporation · LFR Glucose Dehydrogenase, Glucose
Cleared on Dec 17, 2014 as substantially equivalent to K131366 (Roche Diagnostics Operations, Inc., 2013) after a 138-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Dec 17, 2014
- Review
- 138 days
- Class
- Class II
- Product code
- LFR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K010362 (2001). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 5 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- 4 generations backK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
- 3 generations backK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
- 2 generations backK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- 1 generation backK131366 Accu-Chek Aviva Expert Blood Glucose Monitoring SystemRoche Diagnostics Operations, Inc. · 2013
- This deviceK142089 Accu-Chek Aviva Expert SystemRoche Diagnostics Corporation · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −5 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| −4 | K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics Corp. | 2006 | 1 |
| −3 | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | Roche Diagnostics | 2011 | — |
| −2 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| −1 | K131366 | Accu-Chek Aviva Expert Blood Glucose Monitoring System | Roche Diagnostics Operations, Inc. | 2013 | — |
| 0 (this device) | K142089 | Accu-Chek Aviva Expert System | Roche Diagnostics Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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 LFR? 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 |
|---|---|---|---|
| * | K131366 | Accu-Chek Aviva Expert Blood Glucose Monitoring SystemSummary page 6…age 6 === 3) Predicate device The predicate device for this submission is the ACCU-CHEK® Aviva Expert Blood Glucose Monitoring system, cleared in #k131366. Predicate Device Intended Use Statement: The ACCU-CHEK Aviva Expert System is indicated as an ai… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 12 ancestors have a recall of any class.
How does its category compare?
All LFR devicesLFR Glucose Dehydrogenase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 Expert System is indicated as an aid in the treatment of insulin-requiring diabetes. The ACCU-CHEK Aviva Expert System consists of the ACCU-CHEK Aviva Expert Meter, ACCU-CHEK Aviva Plus test strips, ACCU-CHEK Aviva control solutions, and ACCU-CHEK Bolus Advisor. The ACCU-CHEK Aviva Expert System is intended to facilitate the optimization of glycemic control in patients who are trained in multiple daily insulin injection therapy and…
Read the full statement (341 words)
The ACCU-CHEK Aviva Expert System is indicated as an aid in the treatment of insulin-requiring diabetes. The ACCU-CHEK Aviva Expert System consists of the ACCU-CHEK Aviva Expert Meter, ACCU-CHEK Aviva Plus test strips, ACCU-CHEK Aviva control solutions, and ACCU-CHEK Bolus Advisor. The ACCU-CHEK Aviva Expert System is intended to facilitate the optimization of glycemic control in patients who are trained in multiple daily insulin injection therapy and are under the supervision of healthcare professionals experienced in managing insulin treated patients.
The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used by a single person and should not be shared. The ACCU-CHEK Aviva Expert blood glucose monitoring system should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should NOT be used with the ACCU-CHEK Aviva Expert blood glucose monitoring system. The ACCU-CHEK Aviva Expert System is intended for prescription home use only.
The ACCU-CHEK Aviva Expert meter is also indicated for the calculation of an insulin dose or carbohydrate intake based on user-entered data. The ACCU-CHEK Bolus Advisor, as a component of the Accu-Chek Aviva Expert meter, is intended for use in providing insulin dose recommendations in response to blood glucose, health events, and carbohydrate input. The ACCU-CHEK Bolus Advisor is intended to provide direction for insulin adjustment within the scope of a pre-planned treatment program from a healthcare professional. Before its use, a physician or healthcare professional must prescribe the ACCU-CHEK Aviva Expert System and provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the ACCU-CHEK Bolus Advisor. Once programmed, a patient must consult with his/her physician or healthcare professional before making any changes to these ACCU-CHEK Bolus Advisor settings.
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/K142089 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142089: Accu-Chek Aviva Expert System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142089
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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