Cleared Traditional

K111308 - ZYTO HAND CRADLE

K111308 is an FDA 510(k) clearance for ZYTO HAND CRADLE, manufactured by Zyto Technologies, Inc.. The device is a Class 2 Neurology device with product code GZO cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K111308 · Zyto Technologies, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
112d
Days
Class 2
Risk

K111308 is an FDA 510(k) clearance for the ZYTO HAND CRADLE. Classified as Device, Galvanic Skin Response Measurement (product code GZO), Class II - Special Controls.

Submitted by Zyto Technologies, Inc. (Lindon, US). The FDA issued a Cleared decision on August 30, 2011 after a review of 112 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K111308

510(k) Number K111308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2011
Decision Date August 30, 2011
Days to Decision 112 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
37d faster than avg
Panel avg: 149d · This submission: 112d
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.

Regulatory Peers - GZO Device, Galvanic Skin Response Measurement

All 24
Devices cleared under the same product code (GZO) and FDA review panel - the closest regulatory comparables to K111308.
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K111308 · ZYTO HAND CRADLE
Download PDF FDA Summary Zyto Technologies, In…