FDA product code · Neurology · Class 2
JXG: Shunt, Central Nervous System And Components
JXG is FDA's product code for "Shunt, Central Nervous System And Components": a Class 2 device classified under 21 CFR 882.5550, reviewed by the Neurology panel. FDA flags it as an implant.
510(k) review time for JXG
Across 34 510(k) clearances under JXG decided from 2018-01-01 to 2026-10-06, the median was 103 days from FDA receipt to decision. Half took between 89 and 192 days, and 80% were decided within 244 days. These are past clearances, not a forecast for a new submission.
| Fastest | 27 |
|---|---|
| 25th percentile | 89 |
| Median | 103 |
| 75th percentile | 192 |
| 80th percentile | 244 |
| 90th percentile | 266 |
| Slowest | 385 |
| Year | Median days | n |
|---|---|---|
| 2018 | 102 | 6 |
| 2023 | 134 | 5 |
| 2025 | 255 | 8 |
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.
JXG in the public FDA record
| 510(k) clearances, all years | 259 |
|---|---|
| Device recalls | 108 |
| Establishment listings | 587 |
| GUDID device identifiers | 4,115 |
Counts of records, not of devices or events. Adverse event reports for JXG 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 JXG
5 FDA recognized consensus standards cite JXG, 2 of them recognized only in part, among them ISO 7197 Third edition 2006-06-01; ASTM F647-22; ASTM F647-94 (Reapproved 2014). Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 17-12 ISO 7197 Third edition 2006-06-01 — Neurosurgical Implants - Sterile single-use hydrocephalus shunts and components [Including: Technical Corrigendum 1 (2007)]
- 17-21 ASTM F647-22 (partial recognition) — Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
- 17-4 ASTM F647-94 (Reapproved 2014) (partial recognition) — Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
- 5-108 ISO 80369-6 First Edition 2016-03-15 — Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications.
- 5-146 ISO 80369-6 Second edition 2025-05 — Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.