Cleared Traditional

K260578 - Ambu NeurolineTM Cup MRI/CT (Models 727...

K260578 is the FDA 510(k) clearance for Ambu NeurolineTM Cup MRI/CT (Models 727... by Ambu A/S. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K260578 · Ambu A/S · Neurology device
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Optimized for regulatory review, auditing and printing
Jul 2026
Decision
144d
Days
Class 2
Risk

K260578 is an FDA 510(k) clearance for the Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 727.... Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Ambu A/S (Ballerup, DK). The FDA issued a Cleared decision on July 14, 2026 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ambu A/S devices

Submission Details

510(k) Number K260578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2026
Decision Date July 14, 2026
Days to Decision 144 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 148d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 Neurology devices follow this clearance model.

Regulatory Consultant

Ambu, Inc.
SANJAY PARIKH

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GXY Electrode, Cutaneous

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