Cleared Traditional

K241910 - Neonav ECG Tip Location System

K241910 is an FDA 510(k) clearance for Neonav ECG Tip Location System, manufactured by Navi Medical Technologies. The device is a Class 2 Cardiovascular device with product code LJS cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K241910 · Navi Medical Technologies · Cardiovascular device
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Jan 2025
Decision
202d
Days
Class 2
Risk

K241910 is an FDA 510(k) clearance for the Neonav ECG Tip Location System. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Navi Medical Technologies (Carlton, AU). The FDA issued a Cleared decision on January 19, 2025 after a review of 202 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 880.5970 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Navi Medical Technologies devices

FDA 510(k) Submission Details - K241910

510(k) Number K241910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2024
Decision Date January 19, 2025
Days to Decision 202 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 125d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJS Device Classification - Class 2, Special Controls

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 196
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K241910.
Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM)
K251212 · Access Vascular, Inc. · Jul 2025
PM2+ System and SmartPICC Stylet
K243484 · Piccolo Medical, Inc. · May 2025
pilot TLS
K241587 · Vygon Corporation · Feb 2025
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201)
K243941 · Access Vascular, Inc. · Jan 2025
PM2 System and ECGuide Connector
K240486 · Piccolo Medical, Inc. · Sep 2024
CATHTONG III Tapered PICC Catheter
K233149 · L&Z Us, Inc. · Dec 2023