Product code JXG: 510(k) clearances and predicates
Product code JXG covers Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684). FDA lists 259 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
259 clearances on file under product code JXG. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 4 |
| 2023 | 5 |
| 2024 | 3 |
| 2025 | 8 |
| 2026 so far | 1 |
Recent clearances
Newest JXG clearances in the FDA index, with applicant and decision date:
- K261004, Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684), applicant Integra Lifesciences Production Corporation, decided 2026-06-23. FDA record
- K251598, Intellidrop, applicant Brainspace, Inc., decided 2025-12-10. FDA record
- K250636, Sophy Mini Monopressure Valve (SM1), applicant Sophysa, decided 2025-11-28. FDA record
- K252514, EVAC-MRI, applicant Phasor Health, LLC, decided 2025-11-05. FDA record
- K243531, Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology, applicant Integra Lifesciences Production Corporation, decided 2025-08-08. FDA record
- K243552, Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762), applicant Integra Lifesciences Production Corporation, decided 2025-08-06. FDA record
- K242974, External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters, applicant Sophysa, decided 2025-06-20. FDA record
- K243205, EVAC, applicant Phasor Health, LLC, decided 2025-06-03. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Intellidrop, Sophy Mini Monopressure Valve (SM1). Watch new JXG clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code JXG?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent JXG clearances include Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684).
How many 510(k) clearances use product code JXG?
259 at the time this page was generated, from openFDA records.
How do I find a predicate device under JXG?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new JXG clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.