FDA product code JGS: Electrode, Ion Specific, Sodium
JGS is the FDA product code for electrode, ion specific, sodium. It is a Class II device, regulated under 21 CFR 862.1665 and reviewed by the Clinical Chemistry panel. FDA has cleared 162 510(k) submissions under JGS, 5 in the last five years, from 80 different applicants. The average 510(k) review took 95 days (median 64); 267 days on average over the last three years. FDA has posted 48 recalls for JGS devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Ion Specific, Sodium |
| Device class | Class II |
| Regulation | 21 CFR 862.1665 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JGS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 234 |
| 2018 | 3 | 176 |
| 2019 | 3 | 268 |
| 2020 | 2 | 230 |
| 2022 | 1 | 132 |
| 2023 | 3 | 362 |
| 2026 | 1 | 267 |
Compare with all 510(k) review times · Search every JGS clearance
Top JGS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nova Biomedical Corp. | 18 | 2000-08-07 |
| Medica Corp. | 9 | 2011-01-14 |
| Instrumentation Laboratory CO | 5 | 2019-02-16 |
| Diamond Diagnostics, Inc. | 4 | 2012-08-22 |
| Ciba Corning Diagnostics Corp. | 4 | 1993-08-19 |
75 more applicants have JGS clearances. See the full list in Caduvo.
Most recent JGS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252475 | Radiometer Medicals Aps | ABL90 FLEX PLUS System | 2026-05-01 | 267 |
| K230275 | Abbott Point of Care, Inc. | i-STAT CG8+ cartridge with the i-STAT 1 System | 2023-10-27 | 268 |
| K222438 | Siemens Healthcare Diagnostics, Inc. | A-LYTE® Integrated Multisensor (IMT Na K Cl) | 2023-07-25 | 347 |
| K220977 | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer | 2023-07-20 | 472 |
| K213486 | Abbott Laboratories | GLP systems Track | 2022-03-10 | 132 |
Recalls for JGS devices
48 product recalls in 34 recall events; 6 initiated in the last five years and 9 still open. Most recent: 2025-07-07.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2019 | 6 |
| 2020 | 4 |
| 2021 | 4 |
| 2023 | 4 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code JGS?
JGS is the FDA product code for electrode, ion specific, sodium. It is a Class II device, regulated under 21 CFR 862.1665 and reviewed by the Clinical Chemistry panel.
What device class is JGS?
Class II, regulation 21 CFR 862.1665. Typical premarket route: 510(k).
How long does a 510(k) take for product code JGS?
Across 162 cleared submissions the average was 95 days from receipt to decision (median 64).
Which companies have the most JGS clearances?
Nova Biomedical Corp. (18); Medica Corp. (9); Instrumentation Laboratory CO (5); Diamond Diagnostics, Inc. (4); Ciba Corning Diagnostics Corp. (4).
Have JGS devices been recalled?
Yes: 48 product recalls across 34 recall events; the most recent began 2025-07-07.
Next steps
- Run an FDA pathway report with predicate devices for product code JGS
- Run a recall and safety report across every JGS manufacturer
- Watch product code JGS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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