Product code LJS: 510(k) clearances and predicates
Product code LJS covers Neonav ECG Tip Location System. FDA lists 302 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
302 clearances on file under product code LJS. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 3 |
| 2023 | 4 |
| 2024 | 1 |
| 2025 | 8 |
| 2026 so far | 1 |
Recent clearances
Newest LJS clearances in the FDA index, with applicant and decision date:
- K260929, Neonav ECG Tip Location System, applicant Navi Medical Technologies, decided 2026-04-17. FDA record
- K252373, BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology, applicant Spectrum Vascular, decided 2025-12-16. FDA record
- K252792, PM2 System with ECGuide Connector, applicant Piccolo Medical, Inc., decided 2025-11-17. FDA record
- K243458, HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr, applicant Access Vascular, Inc., decided 2025-08-01. FDA record
- K251212, Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM), applicant Access Vascular, Inc., decided 2025-07-01. FDA record
- K243484, PM2+ System and SmartPICC Stylet, applicant Piccolo Medical, Inc., decided 2025-05-29. FDA record
- K241587, pilot TLS, applicant Vygon Corporation, decided 2025-02-26. FDA record
- K241910, Neonav ECG Tip Location System, applicant Navi Medical Technologies, decided 2025-01-19. 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 BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology, PM2 System with ECGuide Connector. Watch new LJS 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 LJS?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent LJS clearances include Neonav ECG Tip Location System.
How many 510(k) clearances use product code LJS?
302 at the time this page was generated, from openFDA records.
How do I find a predicate device under LJS?
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 LJS clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
Get this for LJS, every week.
$49/month. Unlimited codes, one seat covers every client. Cancel anytime.
7-day free trial on the monthly plan. Card required, pay nothing for 7 days. 7-day money-back guarantee. Secure checkout via Stripe.
Not ready? Get one free LJS brief
Tell us where to send it. No card required.
You are on the list.
We will email your free LJS brief shortly. LJS is already in your watchlist draft. Want the ongoing watch instead of one brief? See the 7-day free trial.
Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.