510(k) · Cleared
ClearedHI Chem Electrolyte Reference Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hichem Diagnostics · JGS Electrode, Ion Specific, Sodium
Cleared on Feb 23, 1993 after a 110-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.
- Decided
- Feb 23, 1993
- Review
- 110 days
- Class
- Class II
- Product code
- JGS
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK925611 HI Chem Electrolyte Reference ReagentHichem Diagnostics · 1993
- Descendant · cites it directly · 0 of its ownK040971 Genchem Ise Electrolyte ReferenceGenchem, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K040971Genchem Ise Electrolyte ReferenceGenchem, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925611 | HI Chem Electrolyte Reference Reagent | Hichem Diagnostics | 1993 | — |
| +1 | K040971 | Genchem Ise Electrolyte Reference | Genchem, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 JGS? 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 JGS device
- #1 K252475 ABL90 FLEX PLUS Systemscore 12.2 · 4 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040971 | Genchem Ise Electrolyte Reference | 2004 | 0 |
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, K040971 (Genchem, Inc., 2004) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JGS devicesJGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JGS
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JGS
347in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JGS
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JGS
64in 2025
MAUDE reports naming product code JGS, 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 | — | 7 | 33 |
| 2008 | 2 | — | 1 | 3 |
| 2009 | 2 | — | 0 | 57 |
| 2010 | 1 | — | 1 | 361 |
| 2011 | 3 | 191 | 1 | 912 |
| 2012 | 1 | — | 2 | 412 |
| 2013 | 2 | — | 5 | 510 |
| 2014 | 1 | — | 0 | 251 |
| 2015 | 1 | — | 1 | 158 |
| 2016 | 4 | 198 | 0 | 84 |
| 2017 | 1 | — | 0 | 292 |
| 2018 | 3 | 180 | 0 | 158 |
| 2019 | 3 | 58 | 5 | 105 |
| 2020 | 2 | — | 1 | 89 |
| 2021 | 0 | — | 1 | 91 |
| 2022 | 1 | — | 0 | 60 |
| 2023 | 3 | 347 | 4 | 98 |
| 2024 | 0 | — | 0 | 96 |
| 2025 | 0 | — | 0 | 64 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K925611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925611: HI Chem Electrolyte Reference Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925611
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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