510(k) · Cleared
ClearedSynermed ISE Reagents
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infrared Laboratory Systems, LLC (Dba Synermed) · JGS Electrode, Ion Specific, Sodium
Cleared on Jul 10, 2018 as substantially equivalent to K952179 (Synermed, Inc., 1995) after a 64-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jul 10, 2018
- Review
- 64 days
- Class
- Class II
- Product code
- JGS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952179 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK952179 Synermed Ise ReagentsSynermed, Inc. · 1995
- This deviceK181201 Synermed ISE ReagentsInfrared Laboratory Systems, LLC (Dba Synermed) · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952179 | Synermed Ise Reagents | Synermed, Inc. | 1995 | — |
| 0 (this device) | K181201 | Synermed ISE Reagents | Infrared Laboratory Systems, LLC (Dba Synermed) | 2018 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K952179 | Synermed Ise ReagentsSummary page 4…Class II 75 6. Identification of Predicates: K-number Manufacturer Trade Method Name K952179 Synermed Synermed Ion Selective ISE Electrode… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All JGS devicesJGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Synermed ISE Reagents are used for in-vitro diagnostic use to quantitate levels of Sodium, Potassium and Chloride in serum. This device is for use in clinical laboratories only. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181201 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181201: Synermed ISE Reagents.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181201
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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