510(k) · Cleared
Recalled · 2009Modification to Accu-Chek Active System
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 Jul 3, 2002 as substantially equivalent to K012324 (Roche Diagnostics Corp., 2001) and 1 other predicate after a 29-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 3, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- NBW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K945887 (1995). 15 ancestors in all, the oldest K922888 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 4 generations backK970707 Elect II Blood Glucose Monitoring SystemSelfcare, Inc. · 1997
- 3 generations backK992684 Freestyle Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2000 · Recalled
- 2 generations backK012324 Accu-Chek Active Test SystemRoche Diagnostics Corp. · 2001
- 1 generation backK021448 Modification to Accu-Chek Active SystemRoche Diagnostics Corp. · 2002
- This deviceK021827 Modification to Accu-Chek Active SystemRoche Diagnostics Corp. · 2002
- Descendant · cites it directly · 0 of its ownK163087 PixoTest Blood Glucose Monitoring SystemIxensor Company, Ltd. · 2017
Most influential descendants
Showing 1 of 1 · See all- K163087PixoTest Blood Glucose Monitoring SystemIxensor Company, Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −4 | K970707 | Elect II Blood Glucose Monitoring System | Selfcare, Inc. | 1997 | — |
| −3 | K992684 | Freestyle Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2000 | 2 |
| −2 | K012324 | Accu-Chek Active Test System | Roche Diagnostics Corp. | 2001 | — |
| −1 | K021448 | Modification to Accu-Chek Active System | Roche Diagnostics Corp. | 2002 | — |
| 0 (this device) | K021827 | Modification to Accu-Chek Active System | Roche Diagnostics Corp. | 2002 | — |
| +1 | K163087 | PixoTest Blood Glucose Monitoring System | Ixensor Company, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 3 | 0 |
| 2000 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K012324 | Accu-Chek Active Test System | 2001 |
| * | K021448 | Modification to Accu-Chek Active SystemSummary page 1…(21 C.F.R. 5 862.1345)(75NBW) 3) Predicate We claim substantial equivalence to the current legally marketed Accu-Chek device Active System (KO12324 & K021448) 4) Device Instrument Operating Principle -- photometry Description Reagent Test Principle -- glucose dehydrogena… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163087 | PixoTest Blood Glucose Monitoring System | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 13, 2009 | Not classified | Z-1591-2009 | Other | The lancet cap may be missing, which could result in an unintended lancet stick to the user. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K163087 (Ixensor Company, Ltd., 2017) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K012324.
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 Active system is designed to quantitatively measure the concentration of glucose in capillary whole blood. The device is indicated for professional use and over-the-counter sale.
The Accu-Chek Active system is indicated for use with capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh, calf and palm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021827 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021827: Modification to Accu-Chek Active System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021827
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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