510(k) · Cleared
ClearedVivaChek Link Plus 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 Dec 22, 2023 as substantially equivalent to K173140 (Vivachek Laboratories, Inc., 2018) after an 88-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Dec 22, 2023
- Review
- 88 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000318 (2000). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK000318 Bionostics Glucose Quality Control Solution for Use with the…Bionostics, Inc. · 2000
- 3 generations backK022769 Lifescan Onetouch Ultra Control SolutionBionostics, Inc. · 2002
- 2 generations backK160179 VivaChek Ino Blood Glucose Monitoring SystemVivachek Laboratories, Inc. · 2017
- 1 generation backK173140 VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino…Vivachek Laboratories, Inc. · 2018
- This deviceK233058 VivaChek Link Plus Blood Glucose Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK243060 TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000318 | Bionostics Glucose Quality Control Solution for Use with the Fasttake Compact… | Bionostics, Inc. | 2000 | — |
| −3 | K022769 | Lifescan Onetouch Ultra Control Solution | Bionostics, Inc. | 2002 | — |
| −2 | K160179 | VivaChek Ino Blood Glucose Monitoring System | Vivachek Laboratories, Inc. | 2017 | — |
| −1 | K173140 | VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood… | Vivachek Laboratories, Inc. | 2018 | — |
| 0 (this device) | K233058 | VivaChek Link Plus Blood Glucose Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023 | — |
| +1 | K243060 | TeleRPM Gen2 Blood Glucose Monitoring System | Guangdong Transtek Medical Electronics Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K173140 | VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose…Summary page 4…lass II §862.1345 Glucose Test System Product Code: NBW Predicate Device: VivaChek Ino Smart Blood Glucose Monitoring System VivaChek Laboratories, Inc. 510(k) Number: k173140 1/ 6 Applicant: VivaChek Biotech (Hangzh… | 2018 |
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 |
|---|---|---|---|
| K243060 | TeleRPM Gen2 Blood Glucose Monitoring System | 2025 | 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?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K243060 (Guangdong Transtek Medical Electronics Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K173140.
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. 2023, 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™ Link Plus Blood Glucose Monitoring System is comprised of the VivaChek™ Link Plus Blood Glucose Meter and the VivaChek™ Ino Blood Glucose Test Strips.
VivaChek™ Link Plus 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 as stated in the FDA summary.
https://510kreport.com/device/K233058 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233058: VivaChek Link Plus Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233058
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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