Cleared Traditional

K101691 - LIFELINES PHOTIC STIMULATOR

K101691 is an FDA 510(k) clearance for LIFELINES PHOTIC STIMULATOR, manufactured by Lifelines , Ltd.. The device is a Class 2 Neurology device with product code GWE cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K101691 · Lifelines , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
55d
Days
Class 2
Risk

K101691 is an FDA 510(k) clearance for the LIFELINES PHOTIC STIMULATOR. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Lifelines , Ltd. (Crofton, US). The FDA issued a Cleared decision on August 10, 2010 after a review of 55 days - a notably fast clearance 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: 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 Lifelines , Ltd. devices

FDA 510(k) Submission Details - K101691

510(k) Number K101691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2010
Decision Date August 10, 2010
Days to Decision 55 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 148d · This submission: 55d
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 30
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