510(k) · Cleared
Recalled · Class II · 2024ACCU-CHEK Guide Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diabetes Care, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Aug 31, 2016 as substantially equivalent to K141867 (Roche Diagnostics, 2015) and 1 other predicate after a 148-day review. Its family tree reaches back 6 generations to 2001. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 31, 2016
- Review
- 148 days
- Class
- Class II
- Product code
- NBW
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 6 generations to K010362 (2001). 7 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- 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 backK133862 Accu-Chek Aviva Plus SystemRoche Diagnostics Corporation · 2014 · Recalled
- 1 generation backK141867 Accu-Chek Aviva Connect Blood Glucose Monitoring SystemRoche Diagnostics · 2015
- This deviceK160944 ACCU-CHEK Guide Blood Glucose Monitoring SystemRoche Diabetes Care, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK213131 Accu-Chek Guide Solo diabetes manager blood glucose monitoring systemRoche Diabetes Care GmbH · 2023
- Descendant · cites it directly · 0 of its ownK203711 IWL2020 Blood Glucose Monitoring SystemRoche Diabetes Care, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK181131 Accu-Chek Guide Me Blood Glucose Monitoring SystemRoche Diabetes Care · 2018
Most influential descendants
Showing 3 of 3 · See all- K213131Accu-Chek Guide Solo diabetes manager blood glucose monitoring systemRoche Diabetes Care GmbH · 2023 · cites it directly0descendants
- K203711IWL2020 Blood Glucose Monitoring SystemRoche Diabetes Care, Inc. · 2022 · cites it directly0descendants
- K181131Accu-Chek Guide Me Blood Glucose Monitoring SystemRoche Diabetes Care · 2018 · cites it directly0descendants
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 | K133862 | Accu-Chek Aviva Plus System | Roche Diagnostics Corporation | 2014 | 2 |
| −1 | K141867 | Accu-Chek Aviva Connect Blood Glucose Monitoring System | Roche Diagnostics | 2015 | — |
| 0 (this device) | K160944 | ACCU-CHEK Guide Blood Glucose Monitoring System | Roche Diabetes Care, Inc. | 2016 | — |
| +1 | K213131 | Accu-Chek Guide Solo diabetes manager blood glucose monitoring system | Roche Diabetes Care GmbH | 2023 | — |
| +1 | K203711 | IWL2020 Blood Glucose Monitoring System | Roche Diabetes Care, Inc. | 2022 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K141867 | Accu-Chek Aviva Connect Blood Glucose Monitoring SystemSummary page 5…nassayed) 1 510(k) Summary 3. Predicate Device Accu-Chek Aviva Connect Blood Glucose Monitoring System (k141867), concurrence received on March 3, 2015. The Accu-Chek Aviva Controls (k043474), concurrence received on April 27, 2005. The Acc… | 2015 |
| * | K043474 | Accu-Chek Aviva SystemSummary page 5…= Page 5 === 3. Predicate Device Accu-Chek Aviva Connect Blood Glucose Monitoring System (k141867), concurrence received on March 3, 2015. The Accu-Chek Aviva Controls (k043474), concurrence received on April 27, 2005. The Accu-Chek Aviva Connect Blood Glucose Monitoring System is intended for the quanti… | 2005 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 13, 2024 | Class II | Z-2174-2024 | Reprocessing Controls | The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure. Which may subsequently cause an error in interpreting a result as approximately 18 times… |
| Sep 30, 2019 | Class II | Z-0747-2020 | Device Design | Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K213131 (Roche Diabetes Care GmbH, 2023) has gone furthest, with 0 descendants of its own.
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. 2016, 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 Guide Blood Glucose Monitoring System is comprised of the Accu-Chek Guide meter and the Accu-Chek Guide test strips. The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide Blood Glucose Monitoring System is intended for in vitro diagnostic…
Read the full statement (162 words)
The Accu-Chek Guide Blood Glucose Monitoring System is comprised of the Accu-Chek Guide meter and the Accu-Chek Guide test strips.
The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control.
The Accu-Chek Guide Blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes.
The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use.
Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
Accu-Chek Guide Control Solutions are for use with the Accu-Chek Guide Blood Glucose Monitoring System to check that the meters and test strips are working together properly and that the test is performing correctly.
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/K160944 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160944: ACCU-CHEK Guide 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/K160944
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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