510(k) · Cleared
ClearedVivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vivachek Biotech (Hangzhou) Co., Ltd. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Aug 16, 2024 as substantially equivalent to K190579 (Taidoc Technology Corporation, 2019) after a 760-day review. Its family tree reaches back 5 generations to 2003.
- Decided
- Aug 16, 2024
- Review
- 760 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K031755 (2003). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK031755 Accu-Chek Compact Test StripRoche Diagnostics Corp. · 2003
- 4 generations backK040796 Accu-Chek GO SystemRoche Diagnostics Corp. · 2004 · Recalled
- 3 generations backK082169 Pro Glucose Test StripTaidoc Technology Corporation · 2008
- 2 generations backK100322 TD-4277 Blood Glucose Monitoring System, Model 4277Taidoc Technology Corporation · 2010
- 1 generation backK190579 TD-4183 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2019
- This deviceK222126 VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart…Vivachek Biotech (Hangzhou) Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K031755 | Accu-Chek Compact Test Strip | Roche Diagnostics Corp. | 2003 | — |
| −4 | K040796 | Accu-Chek GO System | Roche Diagnostics Corp. | 2004 | 2 |
| −3 | K082169 | Pro Glucose Test Strip | Taidoc Technology Corporation | 2008 | — |
| −2 | K100322 | TD-4277 Blood Glucose Monitoring System, Model 4277 | Taidoc Technology Corporation | 2010 | — |
| −1 | K190579 | TD-4183 Blood Glucose Monitoring System | Taidoc Technology Corporation | 2019 | — |
| 0 (this device) | K222126 | VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood… | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K190579 | TD-4183 Blood Glucose Monitoring SystemSummary page 7…io.com Tel: +86 571 8918 9521 Product Code: NBW 2.4 Predicate (Legally Marketed) Device Predicate Name: TD-4183 Blood Glucose Monitoring System. 510(k) Number: K190579. Applicant: TaiDoc Technology Corporation. No reference device was used in this submission. 3. Devices Description Viva… | 2019 |
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 21 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 7 ancestors has a recall of any class.
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. 2024, 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?
VivaChek™ Fad Blood Glucose Monitoring System is comprised of the VivaChek™ Fad Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips. VivaChek™ Fad Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not…
Read the full statement (339 words)
VivaChek™ Fad Blood Glucose Monitoring System is comprised of the VivaChek™ Fad Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips.
VivaChek™ Fad Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
VivaChek™ Fad Smart Blood Glucose Monitoring System is comprised of the VivaChek™ Fad Smart Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips.
VivaChek™ Fad Smart Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
VivaChek™ Fad Sync Blood Glucose Monitoring System is comprised of the VivaChek™ Fad Sync Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips.
VivaChek™ Fad Sync Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222126 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222126: VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync 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/K222126
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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