510(k) · Cleared
ClearedEasyelectrolyte Analyzer and Rapidlyte Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medica Corp. · CGZ Electrode, Ion-Specific, Chloride
Cleared on May 15, 2000 after a 54-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 10 later devices descend from it.
- Decided
- May 15, 2000
- Review
- 54 days
- Class
- Class II
- Product code
- CGZ
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 4 citing it directly.
- This deviceK000926 Easyelectrolyte Analyzer and Rapidlyte AnalyzerMedica Corp. · 2000
- Descendant · cites it directly · 3 of its ownK072018 BS-200 Chemistry Analyzer, Mode BS-200Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · Recalled
- Descendant · cites it directly · 2 of its ownK082462 Gemlyte Electrolyte Analyzer NA+/K+/CL-/CA++/LI+Diamond Diagnostics, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK112377 BS-400 Chemistry Analyzer, CLC 720 Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- 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
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K072018BS-200 Chemistry Analyzer, Mode BS-200Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · cites it directly3descendants
- K082462Gemlyte Electrolyte Analyzer NA+/K+/CL-/CA++/LI+Diamond Diagnostics, Inc. · 2009 · cites it directly2descendants
- K112377BS-400 Chemistry Analyzer, CLC 720 Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012 · 2 generations on1descendant
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000926 | Easyelectrolyte Analyzer and Rapidlyte Analyzer | Medica Corp. | 2000 | — |
| +1 | K072018 | BS-200 Chemistry Analyzer, Mode BS-200 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | 1 |
| +1 | K082462 | Gemlyte Electrolyte Analyzer NA+/K+/CL-/CA++/LI+ | Diamond Diagnostics, Inc. | 2009 | — |
| +2 | K112377 | BS-400 Chemistry Analyzer, CLC 720 Chemistry Analyzer | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012 | — |
| +1 | K070104 | Prolyte Electrolyte Analyzer | Diamond Diagnostics, Inc. | 2008 | — |
| +2 | K200544 | SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ | Diamond Diagnostics, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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 CGZ? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (10)
4 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, K072018 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2008) has gone furthest, with 3 descendants of its own.
How does its category compare?
All CGZ devicesCGZ Electrode, Ion-Specific, Chloride: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGZ
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · CGZ
Too few CGZ 510(k)s in any year since 2007 to give a median.
Recalls per year · CGZ
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGZ
5in 2025
MAUDE reports naming product code CGZ, 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 | — | 1 | 4 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 5 |
| 2012 | 0 | — | 0 | 30 |
| 2013 | 0 | — | 0 | 42 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 19 |
| 2019 | 0 | — | 2 | 3 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K000926 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000926: Easyelectrolyte Analyzer and Rapidlyte Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000926
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026