FDA product code · Clinical Chemistry · Class 2
JGS: Electrode, Ion Specific, Sodium
JGS is FDA's product code for "Electrode, Ion Specific, Sodium": a Class 2 device classified under 21 CFR 862.1665, reviewed by the Clinical Chemistry panel.
510(k) review time for JGS
Across 13 510(k) clearances under JGS decided from 2018-01-01 to 2026-10-06, the median was 267 days from FDA receipt to decision. Half took between 64 and 347 days, and 80% were decided within 382 days. These are past clearances, not a forecast for a new submission.
| Fastest | 55 |
|---|---|
| 25th percentile | 64 |
| Median | 267 |
| 75th percentile | 347 |
| 80th percentile | 382 |
| 90th percentile | 459 |
| Slowest | 687 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
JGS in the public FDA record
| 510(k) clearances, all years | 162 |
|---|---|
| Device recalls | 48 |
| Establishment listings | 305 |
| GUDID device identifiers | 589 |
Counts of records, not of devices or events. Adverse event reports for JGS are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite JGS
1 FDA recognized consensus standard cite JGS, among them CLSI C29-A2 (Replaces C29-A). Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 7-86 CLSI C29-A2 (Replaces C29-A) — Standardization of Sodium and Potassium Ion Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard - Second Edition
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.