510(k) · Cleared
ClearedSigms B-Hydroxybutarate Procedure NO. 310-UV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sigma Chemical Co. · JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
Cleared on Aug 30, 1985 after a 211-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 42 devices in its family, counting itself, has a Class I recall. 41 later devices descend from it.
- Decided
- Aug 30, 1985
- Review
- 211 days
- Class
- Class I
- Product code
- JIN
- Recalls
- None
- Predicates
- 0
41 later devices descend from it, 1 citing it directly. 1 of the 42 devices in this family, counting this one, has a Class I recall.
- This deviceK850368 Sigms B-Hydroxybutarate Procedure NO. 310-UVSigma Chemical Co. · 1985
- Descendant · cites it directly · 40 of its ownK983504 Precision Xtra Advanced Diabetes Management System, Precision Blood…Medisense, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 19 of its ownK052980 Liberty Glucose Control, Model 2120031Liberty Healthcare Group, Inc. · 2005
- Descendant · 2 generations on · 16 of its ownK040814 Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories · 2004 · Recalled
- Descendant · 3 generations on · 10 of its ownK091547 Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max…Nova Biomedical Corp. · 2010 · Recalled (Class I)
- Descendant · 3 generations on · 8 of its ownK060706 Liberty Normal Glucose Control SolutionLiberty Healthcare Group, Inc. · 2006
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K091547 Nova Max Plus Blood Glucose and B-Ketone Monitor…3 generations on · 2010
Most influential descendants
Showing 5 of 41 · See all- K983504Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips…Medisense, Inc. · 1999 · cites it directly40descendants
- K052980Liberty Glucose Control, Model 2120031Liberty Healthcare Group, Inc. · 2005 · 2 generations on19descendants
- K040814Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories · 2004 · 2 generations on16descendants
- K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control…Nova Biomedical Corp. · 2010 · 3 generations on10descendants
- K060706Liberty Normal Glucose Control SolutionLiberty Healthcare Group, Inc. · 2006 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K850368 | Sigms B-Hydroxybutarate Procedure NO. 310-UV | Sigma Chemical Co. | 1985 | — |
| +1 | K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose… | Medisense, Inc. | 1999 | 1 |
| +2 | K052980 | Liberty Glucose Control, Model 2120031 | Liberty Healthcare Group, Inc. | 2005 | — |
| +2 | K040814 | Modification to Precision Xtra Advanced Diabetes Management System | Abbott Laboratories | 2004 | 3 |
| +3 | K091547 | Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus… | Nova Biomedical Corp. | 2010 | Class I |
| +3 | K060706 | Liberty Normal Glucose Control Solution | Liberty Healthcare Group, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 1 |
| 2011 | 1 | 0 |
| 2013 | 5 | 0 |
| 2016 | 3 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (41)
See all 411 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips… | 1999 | 40 |
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 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 110 Class I recalls
What does this lineage say?
- Of its descendants, K983504 (Medisense, Inc., 1999) has gone furthest, with 40 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K850368 · printed Nov 3, 2026
Cite this page
510(k) Report. “K850368: Sigms B-Hydroxybutarate Procedure NO. 310-UV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K850368
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026