510(k) · Cleared
ClearedAccu-Chek Guide Solo diabetes manager blood glucose monitoring system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diabetes Care GmbH · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Aug 10, 2023 as substantially equivalent to K160944 (Roche Diabetes Care, Inc., 2016) and 1 other predicate after a 682-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Aug 10, 2023
- Review
- 682 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K010362 (2001). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 6 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- 5 generations backK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
- 4 generations backK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
- 3 generations backK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- 2 generations backK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · Recalled
- 1 generation backK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
- This deviceK213131 Accu-Chek Guide Solo diabetes manager blood glucose monitoring systemRoche Diabetes Care GmbH · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −6 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| −5 | K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics Corp. | 2006 | 1 |
| −4 | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | Roche Diagnostics | 2011 | — |
| −3 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| −2 | K141929 | Accu-Chek Connect Diabetes Management App | Roche Diagnostics Corporation | 2015 | 1 |
| −1 | K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015 | 6 |
| 0 (this device) | K213131 | Accu-Chek Guide Solo diabetes manager blood glucose monitoring system | Roche Diabetes Care GmbH | 2023 | — |
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 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K160944 | ACCU-CHEK Guide Blood Glucose Monitoring SystemSummary page 5…Calculator, Drug Dose Regulation Number: 862.1345, 868.1890 Class II Product Code: NBW, NDC Legally Marketed Predicate Devices [21 CFR 807.92(a)(3)] Predicate #: K160944 Predicate Trade Name: Accu-Chek Guide Blood Glucose Monitoring System Product Code: NBW Predicate #: K150910 Predicate Trade Nam… | 2016 |
| * | K150910 | ACCU-CHEK Connect Diabetes Management AppSummary page 5…keted Predicate Devices [21 CFR 807.92(a)(3)] Predicate #: K160944 Predicate Trade Name: Accu-Chek Guide Blood Glucose Monitoring System Product Code: NBW Predicate #: K150910 Predicate Trade Name: Accu-Chek Connect Diabetes Management App Product Code: NDC page… | 2015 |
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 22 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 12 of the 16 ancestors have a recall of any class.
- 2 other devices also cite its predicate K160944.
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. 2023, 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 Solo diabetes manager blood glucose monitoring system is comprised of the Accu-Chek Guide Solo diabetes manager blood glucose meter, Accu-Chek Bolus Advisor and the Accu-Chek Guide test strips. The Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip. The Accu-Chek Guide Solo diabetes manager blood glucose monitoring system…
Read the full statement (257 words)
The Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is comprised of the Accu-Chek Guide Solo diabetes manager blood glucose meter, Accu-Chek Bolus Advisor and the Accu-Chek Guide test strips.
The Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip. The Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use), by individuals with diabetes at home as an aid in monitoring the effectiveness of glucose control.
The Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is intended to be used by a single person and should not be shared.
This Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use.
The Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is comprised of the Accu-Chek Guide Solo diabetes manager blood glucose meter, Accu-Chek Bolus Advisor and the Accu-Chek Guide test strips.
The Accu-Chek Bolus Advisor, as a component of the Accu-Chek Guide Solo diabetes manager, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data. Before its use, a physician or healthcare professional must activate the bolus calculator and provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software. The Accu-Chek bolus advisor is intended for home use.
The Accu-Chek Guide Solo diabetes manager steers the Accu-Chek Solo micropump.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213131 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213131: Accu-Chek Guide Solo diabetes manager blood glucose monitoring system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213131
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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