Cleared Traditional

K051529 - AMBU NEUROLINE GROUND

K051529 is an FDA 510(k) clearance for AMBU NEUROLINE GROUND, manufactured by Ambu, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K051529 · Ambu, Inc. · Neurology device
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Aug 2005
Decision
56d
Days
Class 2
Risk

K051529 is an FDA 510(k) clearance for the AMBU NEUROLINE GROUND. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Ambu, Inc. (Glen Burnie, US). The FDA issued a Cleared decision on August 4, 2005 after a review of 56 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ambu, Inc. devices

FDA 510(k) Submission Details - K051529

510(k) Number K051529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2005
Decision Date August 04, 2005
Days to Decision 56 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
92d faster than avg
Panel avg: 148d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

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 Peers - GXY Electrode, Cutaneous

All 187
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K051529.
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K041953 · Conmedcorp · Aug 2004
BIS PEDIATRIC SENSOR
K041670 · Aspect Medical Systems, Inc. · Jul 2004
AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE
K032278 · Ambu, Inc. · Mar 2004