510(k) · Cleared
ClearedAccu-Chek Aviva Plus Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · LFR Glucose Dehydrogenase, Glucose
Cleared on Sep 21, 2011 as substantially equivalent to K060620 (Roche Diagnostics Corp., 2006) and 1 other predicate after a 499-day review. Its family tree reaches back 3 generations to 2001. 1 of the 49 devices in its family, counting itself, has a Class I recall. 44 later devices descend from it.
- Decided
- Sep 21, 2011
- Review
- 499 days
- Class
- Class II
- Product code
- LFR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K010362 (2001). 4 ancestors in all. 44 later devices descend from it, 4 citing it directly. 1 of the 49 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 2 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- 1 generation backK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
- This deviceK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
- Descendant · cites it directly · 37 of its ownK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- Descendant · 2 generations on · 33 of its ownK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · Recalled
- Descendant · 3 generations on · 32 of its ownK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
- Descendant · 4 generations on · 21 of its ownK160629 InPenCompanion Medical, Inc. · 2016 · Recalled
- Descendant · 5 generations on · 10 of its ownK190487 InPen Dose CalculatorCompanion Medical, Inc. · 2020 · Recalled
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193483 Basal-IQ Technology6 generations on · 2020
Most influential descendants
Showing 5 of 44 · See all- K111353Accu-Check Combo SystemRoche Diagnostics · 2012 · cites it directly37descendants
- K141929Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · 2 generations on33descendants
- K150910ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · 3 generations on32descendants
- K160629InPenCompanion Medical, Inc. · 2016 · 4 generations on21descendants
- K190487InPen Dose CalculatorCompanion Medical, Inc. · 2020 · 5 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −2 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| −1 | K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics Corp. | 2006 | 1 |
| 0 (this device) | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | Roche Diagnostics | 2011 | — |
| +1 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| +2 | K141929 | Accu-Chek Connect Diabetes Management App | Roche Diagnostics Corporation | 2015 | 1 |
| +3 | K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015 | 6 |
| +4 | K160629 | InPen | Companion Medical, Inc. | 2016 | 1 |
| +5 | K190487 | InPen Dose Calculator | Companion Medical, Inc. | 2020 | 1 |
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 |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 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 |
|---|---|---|---|
| * | K060620 | Accu-Chek Aviva Test StripsSummary page 1…21 C.F.R. § 862.1345) NBW, Blood Glucose Test System, Over-the-Counter LER, Glucose Dehydrogenase 3) Predicate ACCU-CHEK Aviva System (K060620 and K043474) device Continued on next page… | 2006 |
| * | K043474 | Accu-Chek Aviva SystemSummary page 1…862.1345) NBW, Blood Glucose Test System, Over-the-Counter LER, Glucose Dehydrogenase 3) Predicate ACCU-CHEK Aviva System (K060620 and K043474) device Continued on next page… | 2005 |
What descends from it? (44)
See all 444 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K111353 (Roche Diagnostics, 2012) has gone furthest, with 37 descendants of its own.
- 1 other device also cites its predicate K060620.
How does its category compare?
All LFR devicesLFR Glucose Dehydrogenase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 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 ann, or palm.
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/K101299 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101299: Accu-Chek Aviva Plus Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101299
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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