510(k) · Cleared
Recalled · Class II · 2021ACCU-CHEK Performa Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Aug 29, 2014 as substantially equivalent to K121679 (Roche Diagnostics, 2012) after a 263-day review. Its family tree reaches back 3 generations to 2001. 3 later devices descend from it. It has been recalled once.
- Decided
- Aug 29, 2014
- Review
- 263 days
- Class
- Class II
- Product code
- NBW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010362 (2001). 6 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 2 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- 1 generation backK121679 Accu-Chek Inform II Blood Glucose Monitoring SystemRoche Diagnostics · 2012 · Recalled
- This deviceK133741 ACCU-CHEK Performa Blood Glucose Monitoring SystemRoche Diagnostics · 2014
- Descendant · cites it directly · 2 of its ownK170079 Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B…Tyson Bioresearch, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK182046 Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B…Tyson Bioresearch, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK182047 Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C…Tyson Bioresearch, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See all- K170079Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose…Tyson Bioresearch, Inc. · 2017 · cites it directly2descendants
- K182046Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose…Tyson Bioresearch, Inc. · 2018 · 2 generations on0descendants
- K182047Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose…Tyson Bioresearch, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −2 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| −1 | K121679 | Accu-Chek Inform II Blood Glucose Monitoring System | Roche Diagnostics | 2012 | 3 |
| 0 (this device) | K133741 | ACCU-CHEK Performa Blood Glucose Monitoring System | Roche Diagnostics | 2014 | — |
| +1 | K170079 | Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood… | Tyson Bioresearch, Inc. | 2017 | — |
| +2 | K182046 | Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood… | Tyson Bioresearch, Inc. | 2018 | — |
| +2 | K182047 | Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood… | Tyson Bioresearch, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 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 |
|---|---|---|---|
| * | K121679 | Accu-Chek Inform II Blood Glucose Monitoring SystemSummary page 4…t system (21 C.F.R. § 862.1345); Class II NBW, Blood Glucose Test System, Over-the-Counter LFR, Glucose Dehydrogenase 3. Predicate Device ACCU-CHEK Inform II System (k121679), concurrence received on 11 October 2012. The ACCU-CHEK Inform II blood glucose monitoring system is intended for testing outsi… | 2012 |
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 |
|---|---|---|---|
| K170079 | Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose… | 2017 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 28, 2021 | Class II | Z-2352-2021 | Package design/selection | Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 5 of the 6 ancestors have a recall of any class.
- Of its descendants, K170079 (Tyson Bioresearch, Inc., 2017) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K121679.
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. 2014, 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 Performa Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in venous whole blood or fresh capillary whole blood from the fingertips. The ACCU-CHEK Performa Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid in monitoring the effectiveness of glucose…
Read the full statement (138 words)
The ACCU-CHEK Performa Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in venous whole blood or fresh capillary whole blood from the fingertips. The ACCU-CHEK Performa Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid in monitoring the effectiveness of glucose control. This system should only be used with single-use, auto-disabling lancing devices.
The ACCU-CHEK Performa Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. This system is also not for neonatal use.
The ACCU-CHEK Performa test strips are for use with the ACCU-CHEK Performa meter to quantitatively measure glucose (sugar) in venous whole blood or fresh capillary whole blood samples from the fingertips.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133741 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133741: ACCU-CHEK Performa Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133741
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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