510(k) · Cleared
ClearedVivaChek Blood Glucose and B-Ketone Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vivachek Biotech (Hangzhou) Co., Ltd. · JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
Cleared on Jun 5, 2020 as substantially equivalent to K170463 (I-Sens, Inc., 2018) after a 228-day review. Its family tree reaches back 8 generations to 1995. 1 of the 16 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 5, 2020
- Review
- 228 days
- Class
- Class I
- Product code
- JIN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K945887 (1995). 15 ancestors in all, the oldest K850368 (1985). No later device cites it as a predicate yet. 1 of the 16 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 7 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 6 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 5 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 4 generations backK983504 Precision Xtra Advanced Diabetes Management System, Precision Blood…Medisense, Inc. · 1999 · Recalled
- 3 generations backK040814 Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories · 2004 · Recalled
- 2 generations backK091547 Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max…Nova Biomedical Corp. · 2010 · Recalled (Class I)
- 1 generation backK170463 KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood…I-Sens, Inc. · 2018
- This deviceK192957 VivaChek Blood Glucose and B-Ketone Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd. · 2020
Class I recalls in this family
- K091547 Nova Max Plus Blood Glucose and B-Ketone Monitor…2 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −7 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −6 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −5 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −4 | K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose… | Medisense, Inc. | 1999 | 1 |
| −3 | K040814 | Modification to Precision Xtra Advanced Diabetes Management System | Abbott Laboratories | 2004 | 3 |
| −2 | K091547 | Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus… | Nova Biomedical Corp. | 2010 | Class I |
| −1 | K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone… | I-Sens, Inc. | 2018 | — |
| 0 (this device) | K192957 | VivaChek Blood Glucose and B-Ketone Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2007 | 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.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemSummary page 5…Revision: 4 Product code: JIN Predicate Device Name: KetoSens Blood β-Ketone Monitoring System Predicate K Number: K170463 Description: VivaChekTM Blood Glucose and β-Ketone Monitoring System (Model: VGM200) is designed to quantitatively measure the… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max…Nova Biomedical Corp. · 2010 · 2 generations back · ◆ on the line of descent in FIG. 110 Class I recalls
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 15 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All JIN devicesJIN Nitroprusside, Ketones (Urinary, Non-Quant.): FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · JIN
2in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · JIN
192in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIN
3in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIN
4in 2025
MAUDE reports naming product code JIN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 192 | 0 | 5 |
| 2019 | 0 | — | 0 | 52 |
| 2020 | 2 | — | 0 | 37 |
| 2021 | 0 | — | 0 | 43 |
| 2022 | 0 | — | 1 | 14 |
| 2023 | 0 | — | 3 | 17 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
VivaChek™ Blood Glucose and β-Ketone Monitoring System is comprised of the VivaChek™ Blood Glucose and β-Ketone Meter (VGM200), the VivaChek™ Ino Blood Glucose Test Strips (VGS01) and the VivaChek™ Blood β-Ketone Test Strips (VKS01). The VivaChek™ Blood Glucose and β-Ketone Monitoring System is intended to quantitatively measure the glucose concentration and/or β-ketone (beta-hydroxybutyrate) concentration in fresh capillary whole blood samples drawn…
Read the full statement (128 words)
VivaChek™ Blood Glucose and β-Ketone Monitoring System is comprised of the VivaChek™ Blood Glucose and β-Ketone Meter (VGM200), the VivaChek™ Ino Blood Glucose Test Strips (VGS01) and the VivaChek™ Blood β-Ketone Test Strips (VKS01).
The VivaChek™ Blood Glucose and β-Ketone Monitoring System is intended to quantitatively measure the glucose concentration and/or β-ketone (beta-hydroxybutyrate) 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/K192957 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192957: VivaChek Blood Glucose and B-Ketone 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/K192957
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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