510(k) · Cleared
ClearedVivaChek Ino Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vivachek Laboratories, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Apr 21, 2017 as substantially equivalent to K002134 (Selfcare, Inc., 2000) and 1 other predicate after a 450-day review. Its family tree reaches back 2 generations to 2000. 4 later devices descend from it.
- Decided
- Apr 21, 2017
- Review
- 450 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000318 (2000). 3 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK000318 Bionostics Glucose Quality Control Solution for Use with the…Bionostics, Inc. · 2000
- 1 generation backK022769 Lifescan Onetouch Ultra Control SolutionBionostics, Inc. · 2002
- This deviceK160179 VivaChek Ino Blood Glucose Monitoring SystemVivachek Laboratories, Inc. · 2017
- Descendant · cites it directly · 3 of its ownK173140 VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino…Vivachek Laboratories, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK233058 VivaChek Link Plus Blood Glucose Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK243060 TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK223722 MIO Blood Glucose Monitoring SystemMio Labs, Inc. · 2023
Most influential descendants
Showing 4 of 4 · See all- K173140VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose…Vivachek Laboratories, Inc. · 2018 · cites it directly3descendants
- K233058VivaChek Link Plus Blood Glucose Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd. · 2023 · 2 generations on1descendant
- K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd. · 2025 · 3 generations on0descendants
- K223722MIO Blood Glucose Monitoring SystemMio Labs, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000318 | Bionostics Glucose Quality Control Solution for Use with the Fasttake Compact… | Bionostics, Inc. | 2000 | — |
| −1 | K022769 | Lifescan Onetouch Ultra Control Solution | Bionostics, Inc. | 2002 | — |
| 0 (this device) | 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 | — |
| +2 | K233058 | VivaChek Link Plus Blood Glucose Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023 | — |
| +3 | K243060 | TeleRPM Gen2 Blood Glucose Monitoring System | Guangdong Transtek Medical Electronics Co., Ltd. | 2025 | — |
| +2 | K223722 | MIO Blood Glucose Monitoring System | Mio Labs, Inc. | 2023 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K002134 | One Touch Ultra Blood Glucose Monitoring SystemSummary page 4…§862.1345 Glucose Test System Predicate Device: One Touch Ultra Blood Glucose Monitoring System Lifescan, Inc., located at 1000 Gibraltar Dr., Milpitas, CA 95035, USA. K002134 LifeScan One Touch Ultra Control Solution Bionostics, Inc., located at 7Jackson Road, Devens, MA01432, USA. 510(k) Number: K0227… | 2000 |
| * | K022769 | Lifescan Onetouch Ultra Control SolutionSummary page 4…braltar Dr., Milpitas, CA 95035, USA. K002134 LifeScan One Touch Ultra Control Solution Bionostics, Inc., located at 7Jackson Road, Devens, MA01432, USA. 510(k) Number: K022769 1/5 Sponsor: VivaChek Labortat… | 2002 |
| † | K913806 | Ysi Model 2300 Stat Plus | 1991 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173140 | VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose… | 2018 | 3 |
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 17 years and passes through 2 companies; a new generation was cleared every 14.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K173140 (Vivachek Laboratories, Inc., 2018) has gone furthest, with 3 descendants of its own.
- 9 other devices also cite its predicate K002134.
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. 2017, 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™ Ino Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Blood Glucose Meter and the VivaChek™ Ino Blood Glucose Test Strips. The VivaChek™ Ino Blood Glucose Monitoring System (Meter Model: VGM01) is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. It allows diabetics to take blood samples from the fingertip, forearm, or palm. It is used at home as a way to monitor the effectiveness of…
Read the full statement (177 words)
VivaChek™ Ino Blood Glucose Monitoring System is comprised of the VivaChek™ Ino Blood Glucose Meter and the VivaChek™ Ino Blood Glucose Test Strips. The VivaChek™ Ino Blood Glucose Monitoring System (Meter Model: VGM01) is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. It allows diabetics to take blood samples from the fingertip, forearm, or palm. It is used at home as a way to monitor the effectiveness of diabetes control programs. Alternate testing sites (forearm and palm) should be used only during steady-state times (when blood glucose level is not changing rapidly). This system is intended to be used by a single patient and should not be shared.
The VivaChek™ Ino Blood Glucose Monitoring System is not used for the diagnosis of or screening of diabetes or for neonatal use.
The VivaChek™ Ino Blood Glucose Control Solution is for use with the VivaChek™ Ino Blood Glucose Meter and Strips as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160179 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160179: VivaChek Ino 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/K160179
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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