510(k) · Cleared
Recalled · 2005Accu-Chek Compact 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 23, 2002 as substantially equivalent to K004010 (Roche Diagnostics Corp., 2001) after a 20-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 23, 2002
- Review
- 20 days
- Class
- Class II
- Product code
- NBW
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K004010 (2001). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK004010 Accu-Chek Compact System, Accu-Chek Compact Test Strips, Accu-Chek…Roche Diagnostics Corp. · 2001
- This deviceK022171 Accu-Chek Compact SystemRoche Diagnostics Corp. · 2002
- Descendant · cites it directly · 2 of its ownK081403 Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK123851 Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK152493 POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. · 2016
Most influential descendants
Showing 3 of 3 · See all- K081403Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc. · 2008 · cites it directly2descendants
- K123851Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc. · 2013 · 2 generations on1descendant
- K152493POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K004010 | Accu-Chek Compact System, Accu-Chek Compact Test Strips, Accu-Chek Compact… | Roche Diagnostics Corp. | 2001 | — |
| 0 (this device) | K022171 | Accu-Chek Compact System | Roche Diagnostics Corp. | 2002 | — |
| +1 | K081403 | Glucose Meter-Check Control Solution for Roche Accu-Chek | Bionostics, Inc. | 2008 | — |
| +2 | K123851 | Glucose Meter-Check Solution for Roche Accu-Chek | Bionostics, Inc. | 2013 | — |
| +3 | K152493 | POGO Automatic Blood Glucose Monitoring System | Intuity Medical, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K004010 | Accu-Chek Compact System, Accu-Chek Compact Test Strips, Accu-Chek Compact Compact… | 2001 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081403 | Glucose Meter-Check Control Solution for Roche Accu-Chek | 2008 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 18, 2005 | Not classified | Z-0976-05 | Other | The meter may self-start without a sample having been applied and report erroneous results without an error message if the nose cover is not properly snapped in place and the undosed test strip is bent upwards while the meter is waiting… |
| May 18, 2005 | Not classified | Z-0977-05 | Other | The meter may self-start without a sample having been applied and report erroneous results without an error message if the nose cover is not properly snapped in place and the undosed test strip is bent upwards while the meter is waiting… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K081403 (Bionostics, Inc., 2008) has gone furthest, with 2 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 Compact system is designed to quantitatively measure the concentration of glucose in capillary and venous whole blood. The device is indicated for professional use and over-the-counter sale.
The Accu-Chek Compact system is indicated for lay person 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/K022171 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022171: Accu-Chek Compact System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022171
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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