510(k) · Cleared
Recalled · Class II · 2017Accu-Chek Aviva Plus System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corporation · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Apr 29, 2014 as substantially equivalent to K101299 (Roche Diagnostics, 2011) after a 131-day review. Its family tree reaches back 4 generations to 2001. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 29, 2014
- Review
- 131 days
- Class
- Class II
- Product code
- NBW
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010362 (2001). 5 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 3 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- 2 generations backK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
- 1 generation backK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
- This deviceK133862 Accu-Chek Aviva Plus SystemRoche Diagnostics Corporation · 2014
- Descendant · cites it directly · 4 of its ownK141867 Accu-Chek Aviva Connect Blood Glucose Monitoring SystemRoche Diagnostics · 2015
- Descendant · 2 generations on · 3 of its ownK160944 ACCU-CHEK Guide Blood Glucose Monitoring SystemRoche Diabetes Care, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 0 of its ownK213131 Accu-Chek Guide Solo diabetes manager blood glucose monitoring systemRoche Diabetes Care GmbH · 2023
- Descendant · 3 generations on · 0 of its ownK203711 IWL2020 Blood Glucose Monitoring SystemRoche Diabetes Care, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK181131 Accu-Chek Guide Me Blood Glucose Monitoring SystemRoche Diabetes Care · 2018
Most influential descendants
Showing 5 of 5 · See all- K141867Accu-Chek Aviva Connect Blood Glucose Monitoring SystemRoche Diagnostics · 2015 · cites it directly4descendants
- K160944ACCU-CHEK Guide Blood Glucose Monitoring SystemRoche Diabetes Care, Inc. · 2016 · 2 generations on3descendants
- K213131Accu-Chek Guide Solo diabetes manager blood glucose monitoring systemRoche Diabetes Care GmbH · 2023 · 3 generations on0descendants
- K203711IWL2020 Blood Glucose Monitoring SystemRoche Diabetes Care, Inc. · 2022 · 3 generations on0descendants
- K181131Accu-Chek Guide Me Blood Glucose Monitoring SystemRoche Diabetes Care · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −3 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| −2 | K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics Corp. | 2006 | 1 |
| −1 | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | Roche Diagnostics | 2011 | — |
| 0 (this device) | K133862 | Accu-Chek Aviva Plus System | Roche Diagnostics Corporation | 2014 | — |
| +1 | K141867 | Accu-Chek Aviva Connect Blood Glucose Monitoring System | Roche Diagnostics | 2015 | — |
| +2 | K160944 | ACCU-CHEK Guide Blood Glucose Monitoring System | Roche Diabetes Care, Inc. | 2016 | 2 |
| +3 | K213131 | Accu-Chek Guide Solo diabetes manager blood glucose monitoring system | Roche Diabetes Care GmbH | 2023 | — |
| +3 | K203711 | IWL2020 Blood Glucose Monitoring System | Roche Diabetes Care, Inc. | 2022 | — |
| +3 | K181131 | Accu-Chek Guide Me Blood Glucose Monitoring System | Roche Diabetes Care | 2018 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 NBW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NBW device
- #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | 2011 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141867 | Accu-Chek Aviva Connect Blood Glucose Monitoring System | 2015 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 12, 2017 | Class II | Z-2765-2019 | Process change control | Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on). |
| Jun 12, 2017 | Class II | Z-2766-2019 | Process change control | Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K141867 (Roche Diagnostics, 2015) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K101299.
How does its category compare?
All NBW devicesNBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NBW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBW
243in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBW
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NBW
4,745in 2025
MAUDE reports naming product code NBW, 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 | 29 | 85 | 9 | 7,991 |
| 2008 | 37 | 128 | 2 | 7,704 |
| 2009 | 38 | 140 | 5 | 10,963 |
| 2010 | 31 | 132 | 11 | 11,631 |
| 2011 | 30 | 328 | 1 | 22,909 |
| 2012 | 30 | 230 | 1 | 23,449 |
| 2013 | 47 | 167 | 5 (2) | 35,408 |
| 2014 | 24 | 202 | 1 | 38,524 |
| 2015 | 32 | 237 | 0 | 62,111 |
| 2016 | 20 | 233 | 1 | 76,621 |
| 2017 | 25 | 244 | 0 | 37,538 |
| 2018 | 19 | 168 | 0 | 16,911 |
| 2019 | 10 | 127 | 14 | 14,472 |
| 2020 | 7 | 121 | 0 | 10,703 |
| 2021 | 7 | 465 | 0 | 9,198 |
| 2022 | 12 | 410 | 0 | 8,103 |
| 2023 | 5 | 193 | 0 | 7,256 |
| 2024 | 7 | 243 | 0 | 6,220 |
| 2025 | 2 | — | 1 | 4,745 |
| 2026 | 5 | 190 | 0 | — |
What is it indicated for?
The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended for self testing outside the body (in…
Read the full statement (171 words)
The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The ACCU-CHEK Aviva Plus Test Strips are for use with the ACCU-CHEK Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133862 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133862: Accu-Chek Aviva Plus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133862
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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