Cleared Traditional

K150804 - QBioScan

K150804 is an FDA 510(k) clearance for QBioScan, manufactured by Medeia, Inc.. The device is a Class 2 Neurology device with product code GZO cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K150804 · Medeia, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
207d
Days
Class 2
Risk

K150804 is an FDA 510(k) clearance for the QBioScan. Classified as Device, Galvanic Skin Response Measurement (product code GZO), Class II - Special Controls.

Submitted by Medeia, Inc. (Miami, US). The FDA issued a Cleared decision on October 19, 2015 after a review of 207 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1540 - 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 Medeia, Inc. devices

FDA 510(k) Submission Details - K150804

510(k) Number K150804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2015
Decision Date October 19, 2015
Days to Decision 207 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
59d slower than avg
Panel avg: 148d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZO Device Classification - Class 2, Special Controls

Product Code GZO Device, Galvanic Skin Response Measurement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1540
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.