Cleared Traditional

K181537 - GLOW800 (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
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.

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
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 163d · 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

Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K181537.
IC-Flow™ Imaging System 2.0
K243645 · Diagnostic Green GmbH · Sep 2025
Affirm 800
K243077 · Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) · Jun 2025
Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
K231075 · Carl Zeiss Meditec, Inc. · Jun 2023
DIR 800
K202391 · Aesculap, Inc. · Jan 2021