510(k) · Cleared
ClearedKET-1 Blood Ketone Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apex BioTechnology Corp. · JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
Cleared on Dec 18, 2018 as substantially equivalent to K091547 (Nova Biomedical Corp., 2010) after an 89-day review. Its family tree reaches back 7 generations to 1995. 1 of the 15 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 18, 2018
- Review
- 89 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). No later device cites it as a predicate yet. 1 of the 15 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 deviceK182593 KET-1 Blood Ketone Monitoring SystemApex BioTechnology Corp. · 2018
Class I recalls in this family
- K091547 Nova Max Plus Blood Glucose and B-Ketone Monitor…direct predicate · 2010
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) | K182593 | KET-1 Blood Ketone Monitoring System | Apex BioTechnology Corp. | 2018 | — |
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.
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 4…limitation of exemptions 21 CFR 862.9(c)(5) Product Codes: JIN Predicate Devices: Nova Max Plus Blood Glucose and β-ketone Monitor System (k091547) Device Description: The KET-1 Blood Ketone Monitoring System consists of the KET-1 Blood Ketone Meter,… | 2010 |
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 · 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.
- 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?
The KET-1 Blood Ketone Monitoring System is intended to quantitatively measure B-hydroxybutyrate (f-ketone) in fresh capillary whole blood from fingertips. It should only be used by a single patient and it should not be shared. Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. It is not to be used for diagnosis or screening of diabetes, or for neonatal use.
The KET-1 Blood Ketone Monitoring System is comprised of the KET-1 Blood Ketone Meter and KET-1 Blood Ketone Test Strip.
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/K182593 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182593: KET-1 Blood 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/K182593
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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