Cleared Traditional

GLOW800 (K181537) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181537 · Leica Microsystems (Schweiz) AG · Neurology device
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Sep 2018
Decision
88d
Days
Class 2
Risk

K181537 is an FDA 510(k) clearance for the GLOW800. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Leica Microsystems (Schweiz) AG (Heerbrugg, CH). The FDA issued a Cleared decision on September 7, 2018 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 892.1600 - 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 Leica Microsystems (Schweiz) AG devices

Submission Details

510(k) Number K181537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2018
Decision Date September 07, 2018
Days to Decision 88 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 148d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 - IZI System, X-ray, Angiographic

All 198
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