Cleared Special

K260929 - Neonav ECG Tip Location System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K260929 · Navi Medical Technologies · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2026
Decision
28d
Days
Class 2
Risk

K260929 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 April 17, 2026 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 880.5970 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Navi Medical Technologies devices

Submission Details

510(k) Number K260929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2026
Decision Date April 17, 2026
Days to Decision 28 days
Submission Type Special
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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 301
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