Cleared Traditional

K173861 - Drug Relief (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173861 · Dyansys, Inc. · Neurology device
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May 2018
Decision
133d
Days
Class 2
Risk

K173861 is an FDA 510(k) clearance for the Drug Relief. Classified as Percutaneous Nerve Stimulator For Opioid Withdrawal (product code PZR), Class II - Special Controls.

Submitted by Dyansys, Inc. (San Mateo, US). The FDA issued a Cleared decision on May 2, 2018 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5896 - 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 Dyansys, Inc. devices

Submission Details

510(k) Number K173861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2017
Decision Date May 02, 2018
Days to Decision 133 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
15d faster than avg
Panel avg: 148d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PZR Percutaneous Nerve Stimulator For Opioid Withdrawal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5896
Definition Stimulate Nerve Branches To Aid In The Reduction Of Symptoms Associated With Substance Use Disorders.
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 - PZR Percutaneous Nerve Stimulator For Opioid Withdrawal

All 7
Devices cleared under the same product code (PZR) and FDA review panel - the closest regulatory comparables to K173861.
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