510(k) · Cleared
ClearedAccu-Chek Advantage Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jun 11, 2002 after a 33-day review. The FDA summary names its predicate without a number. 15 later devices descend from it.
- Decided
- Jun 11, 2002
- Review
- 33 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 8 citing it directly.
- This deviceK021513 Accu-Chek Advantage ModuleRoche Diagnostics Corp. · 2002
- Descendant · cites it directly · 6 of its ownK051285 Glucolab Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2005
- Descendant · 2 generations on · 2 of its ownK091157 Gluco Lab Auto Coding, Model Igm-0022Infopia Co, Ltd. · 2009
- Descendant · 3 generations on · 1 of its ownK113192 Healthpro Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK082201 G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024AU. S. Diagnostics, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK052469 GlucopackHealthpia America Corp. · 2006
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K051285Glucolab Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2005 · cites it directly6descendants
- K091157Gluco Lab Auto Coding, Model Igm-0022Infopia Co, Ltd. · 2009 · 2 generations on2descendants
- K113192Healthpro Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2012 · 3 generations on1descendant
- K082201G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024AU. S. Diagnostics, Inc. · 2009 · cites it directly1descendant
- K052469GlucopackHealthpia America Corp. · 2006 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021513 | Accu-Chek Advantage Module | Roche Diagnostics Corp. | 2002 | — |
| +1 | K051285 | Glucolab Blood Glucose Monitoring System | Infopia Co, Ltd. | 2005 | — |
| +2 | K091157 | Gluco Lab Auto Coding, Model Igm-0022 | Infopia Co, Ltd. | 2009 | — |
| +3 | K113192 | Healthpro Blood Glucose Monitoring System | Infopia Co, Ltd. | 2012 | — |
| +1 | K082201 | G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024A | U. S. Diagnostics, Inc. | 2009 | — |
| +1 | K052469 | Glucopack | Healthpia America Corp. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | — | Accu-Chek Complete System Named without a submission number |
What descends from it? (15)
See all 158 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051285 | Glucolab Blood Glucose Monitoring System | 2005 | 6 |
| K082201 | G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024A | 2009 | 1 |
| K052469 | Glucopack | 2006 | 1 |
| K061431 | Easygluco, Model Igm-0002 G2 | 2007 | 0 |
| K051651 | G4, Model Igm-0004 | 2006 | 0 |
| K043512 | Easygluco Igm-0002 G2 | 2005 | 0 |
| K043543 | Blood Glucose Monitoring System | 2005 | 0 |
| K031501 | Easygluco, Model IGM0002 | 2003 | 0 |
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?
- Of its descendants, K051285 (Infopia Co, Ltd., 2005) has gone furthest, with 6 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.
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 Advantage Module is designed for testing glucose in whole blood by persons with diabetes or by health care professionals in the home or in health care facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021513 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021513: Accu-Chek Advantage Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021513
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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