510(k) · Cleared
ClearedKetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I-Sens, Inc. · JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
Cleared on Apr 13, 2018 as substantially equivalent to K091547 (Nova Biomedical Corp., 2010) after a 422-day review. Its family tree reaches back 7 generations to 1995. 1 of the 16 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Apr 13, 2018
- Review
- 422 days
- Class
- Class I
- Product code
- JIN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K945887 (1995). 14 ancestors in all, the oldest K850368 (1985). 1 later device descends from it, 1 citing it directly. 1 of the 16 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 6 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 5 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 4 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 3 generations backK983504 Precision Xtra Advanced Diabetes Management System, Precision Blood…Medisense, Inc. · 1999 · Recalled
- 2 generations backK040814 Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories · 2004 · Recalled
- 1 generation backK091547 Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max…Nova Biomedical Corp. · 2010 · Recalled (Class I)
- This deviceK170463 KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood…I-Sens, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK192957 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…direct predicate · 2010
Most influential descendants
Showing 1 of 1 · See all- K192957VivaChek Blood Glucose and B-Ketone Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −6 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −5 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −4 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −3 | K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose… | Medisense, Inc. | 1999 | 1 |
| −2 | K040814 | Modification to Precision Xtra Advanced Diabetes Management System | Abbott Laboratories | 2004 | 3 |
| −1 | K091547 | Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus… | Nova Biomedical Corp. | 2010 | Class I |
| 0 (this device) | K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone… | I-Sens, Inc. | 2018 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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.
Top candidate predicates for a new JIN device
- #1 K192957 VivaChek Blood Glucose and B-Ketone Monitoring…score 1.6 · 8 generations · no Class I recall
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 |
|---|---|---|---|
| * | K091547 | Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control…Summary page 7…Blood Glucose and β-Ketone Monitor - The Nova Max Plus Ketone Test Strips 3.2 Predicate 510(k) Number k091547 6. Comparison with Predicate Devices Table 1. The Composition Comparison of the Candidate Devices with the Predicate dev… | 2010 |
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 |
|---|---|---|---|
| K192957 | VivaChek Blood Glucose and B-Ketone Monitoring System | 2020 | 0 |
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 · Direct predicate · ◆ on the line of descent in FIG. 110 Class I recalls
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 14 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K192957 (Vivachek Biotech (Hangzhou) Co., Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K091547.
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. 2018, 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?
KetoSens Blood β-Ketone Monitoring System is intended to be used for the quantitative measurement of β-Ketone (beta-hydroxybutyrate) level in capillary whole blood samples drawn from the fingertip. The KetoSens Blood β-Ketone Monitoring Systems are for self-testing outside the body (for in vitro diagnostic use) in the home as an aid to monitor the effectiveness of diabetes control program. The system is not intended for use in the diagnosis of or…
Read the full statement (263 words)
KetoSens Blood β-Ketone Monitoring System is intended to be used for the quantitative measurement of β-Ketone (beta-hydroxybutyrate) level in capillary whole blood samples drawn from the fingertip. The KetoSens Blood β-Ketone Monitoring Systems are for self-testing outside the body (for in vitro diagnostic use) in the home as an aid to monitor the effectiveness of diabetes control program. The system is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. This system is intended to be used by a single person and should not be shared.
The KetoSens Blood β-Ketone Test Strips work with the KetoSens Blood β-Ketone Meter to quantitatively measure Blood β-Ketone in capillary whole blood samples drawn from the fingertip.
KetoSens Multi Blood β-Ketone Monitoring System is intended to be used for the quantitative measurement of β-Ketone (beta-hydroxybutyrate) level in capillary whole blood from the fingertip and venous EDTA whole blood. KetoSens Multi Blood β-Ketone Monitoring System is intended for in vitro diagnostic use and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. The system is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. This system should only be used with single-use, auto-disabling lancing devices.
The KetoSens Multi Blood β-Ketone Test Strips work with the KetoSens Multi Blood β-Ketone Meter to quantitatively measure Blood β-Ketone in capillary whole blood samples drawn from the fingertip and venous whole blood drawn in professional healthcare settings.
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/K170463 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170463: KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood 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/K170463
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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