510(k) · Cleared
ClearedCorning 925 Chloride Meter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corning Medical & Scientific · JFS Coulometric, Chloride
Cleared on Mar 17, 1981 after an 8-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Mar 17, 1981
- Review
- 8 days
- Class
- Class II
- Product code
- JFS
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK810615 Corning 925 Chloride MeterCorning Medical & Scientific · 1981
- Descendant · cites it directly · 2 of its ownK082462 Gemlyte Electrolyte Analyzer NA+/K+/CL-/CA++/LI+Diamond Diagnostics, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK070104 Prolyte Electrolyte AnalyzerDiamond Diagnostics, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK200544 SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK121140 Prolyte Electrolyte AnalyzerDiamond Diagnostics, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK102959 Prolyte Electrolyte AnalyzerDiamond Diagnostics, Inc. · 2011
Most influential descendants
Showing 5 of 5 · See all- K082462Gemlyte Electrolyte Analyzer NA+/K+/CL-/CA++/LI+Diamond Diagnostics, Inc. · 2009 · cites it directly2descendants
- K070104Prolyte Electrolyte AnalyzerDiamond Diagnostics, Inc. · 2008 · cites it directly1descendant
- K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc. · 2020 · 2 generations on0descendants
- K121140Prolyte Electrolyte AnalyzerDiamond Diagnostics, Inc. · 2012 · 2 generations on0descendants
- K102959Prolyte Electrolyte AnalyzerDiamond Diagnostics, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K810615 | Corning 925 Chloride Meter | Corning Medical & Scientific | 1981 | — |
| +1 | K082462 | Gemlyte Electrolyte Analyzer NA+/K+/CL-/CA++/LI+ | Diamond Diagnostics, Inc. | 2009 | — |
| +1 | K070104 | Prolyte Electrolyte Analyzer | Diamond Diagnostics, Inc. | 2008 | — |
| +2 | K200544 | SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ | Diamond Diagnostics, Inc. | 2020 | — |
| +2 | K121140 | Prolyte Electrolyte Analyzer | Diamond Diagnostics, Inc. | 2012 | — |
| +2 | K102959 | Prolyte Electrolyte Analyzer | Diamond Diagnostics, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2020 | 1 | 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.
Planning a device in JFS? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K082462 (Diamond Diagnostics, Inc., 2009) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JFS devicesJFS Coulometric, Chloride: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JFS
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · JFS
Too few JFS 510(k)s in any year since 2007 to give a median.
Recalls per year · JFS
No recall names JFS since 2007.
Adverse event reports per year · JFS
No MAUDE report names JFS since 2007.
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 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K810615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K810615: Corning 925 Chloride Meter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K810615
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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