Cleared Traditional

K173936 - Natus Photic Stimulator

K173936 is an FDA 510(k) clearance for Natus Photic Stimulator, manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The device is a Class 2 Neurology device with product code GWE cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K173936 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Neurology device
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Jun 2018
Decision
171d
Days
Class 2
Risk

K173936 is an FDA 510(k) clearance for the Natus Photic Stimulator. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) (Oakville, CA). The FDA issued a Cleared decision on June 15, 2018 after a review of 171 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1890 - 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 Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) devices

FDA 510(k) Submission Details - K173936

510(k) Number K173936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2017
Decision Date June 15, 2018
Days to Decision 171 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
23d slower than avg
Panel avg: 148d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWE Device Classification - Class 2, Special Controls

Product Code GWE Stimulator, Photic, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1890
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 - GWE Stimulator, Photic, Evoked Response

All 20
Devices cleared under the same product code (GWE) and FDA review panel - the closest regulatory comparables to K173936.
LED PHOTIC System
K211974 · Micromed S.P.A. · Sep 2021
Vision Monitor - MonpackONE
K211643 · Metrovision · Jul 2021
Nurochek System
K200705 · Cryptych Pty, Ltd. · Apr 2020
XLTEK LED GOGGLES, MODEL LED-01
K011794 · Excel Tech. , Ltd. · Oct 2001
EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)
K991903 · Excel Tech. , Ltd. · Aug 1999
KILOWIN
K971214 · Cadwell Laboratories, Inc. · Jun 1998