Product code LJT: 510(k) clearances and predicates
Product code LJT covers FLEXI-PORT Power Injectable Implantable Port. FDA lists 288 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
288 clearances on file under product code LJT. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 so far | 1 |
Recent clearances
Newest LJT clearances in the FDA index, with applicant and decision date:
- K260916, FLEXI-PORT Power Injectable Implantable Port, applicant Portal Access, Inc., decided 2026-06-17. FDA record
- K252478, Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port, applicant Bard Access Systems, Inc., decided 2025-09-05. FDA record
- K251253, PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R.I. isp Implantable Port, applicant Bard Access Systems, Inc., decided 2025-06-18. FDA record
- K242328, PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports, applicant Bard Access Systems, Inc., decided 2024-10-31. FDA record
- K232737, PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG Enabled Implantable Port; PowerPort isp M.R.I. ECG Enabled Implantable Port; PowerPort Slim ECG Enabled Implantable Port, applicant Bard Peripheral Vascular, Inc., decided 2023-12-08. FDA record
- K190559, SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports, applicant AngioDynamics, Inc., decided 2020-05-22. FDA record
- K181446, Bard Power-Injectable Implantable Ports (PowerPorts®), applicant C.R. Bard, Inc., decided 2019-07-08. FDA record
- K151239, NMI DUAL PORT II, applicant Navilyst Medical, Inc., decided 2016-06-06. 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 Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port, PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R.I. isp Implantable Port. Watch new LJT 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 LJT?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent LJT clearances include FLEXI-PORT Power Injectable Implantable Port.
How many 510(k) clearances use product code LJT?
288 at the time this page was generated, from openFDA records.
How do I find a predicate device under LJT?
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 LJT clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.