510(k) · Cleared
ClearedGlucose Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Derma Media Lab., Inc. · CFR Hexokinase, Glucose
Cleared on Aug 1, 1997 after a 161-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Aug 1, 1997
- Review
- 161 days
- Class
- Class II
- Product code
- CFR
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK970664 Glucose ReagentDerma Media Lab., Inc. · 1997
- Descendant · cites it directly · 1 of its ownK112377 BS-400 Chemistry Analyzer, CLC 720 Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- Descendant · 2 generations on · 0 of its ownK140690 BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2014
Most influential descendants
Showing 2 of 2 · See all- K112377BS-400 Chemistry Analyzer, CLC 720 Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012 · cites it directly1descendant
- K140690BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970664 | Glucose Reagent | Derma Media Lab., Inc. | 1997 | — |
| +1 | K112377 | BS-400 Chemistry Analyzer, CLC 720 Chemistry Analyzer | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012 | — |
| +2 | K140690 | BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I Chemistry Analyzer | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CFR? 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 CFR device
- #1 K253490 Glucose HK Gen.3; ONLINE DAT Methadone II…score 11.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112377 | BS-400 Chemistry Analyzer, CLC 720 Chemistry Analyzer | 2012 | 1 |
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?
- Of its descendants, K112377 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CFR devicesCFR Hexokinase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CFR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CFR
115in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CFR
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFR
16in 2025
MAUDE reports naming product code CFR, 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 | 1 | — | 0 | 1 |
| 2008 | 5 | 182 | 7 | 2 |
| 2009 | 3 | 101 | 1 | 7 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 3 | 316 | 0 | 43 |
| 2012 | 4 | 115 | 1 | 49 |
| 2013 | 1 | — | 0 | 36 |
| 2014 | 1 | — | 1 | 2 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 2 | — | 1 | 1 |
| 2017 | 1 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 1 | — | 0 | 16 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Glucose Reagent is to be used to aid in the diagnosis of diabetes mellitus and other associated with glucose abnormalities.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970664 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970664: Glucose Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970664
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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