Cleared Traditional

K201873 - Sparrow Therapy System (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence.

K201873 · Spark Biomedical, Inc. · Neurology device
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Jan 2021
Decision
179d
Days
Class 2
Risk

K201873 is an FDA 510(k) clearance for the Sparrow Therapy System. Classified as Percutaneous Nerve Stimulator For Opioid Withdrawal (product code PZR), Class II - Special Controls.

Submitted by Spark Biomedical, Inc. (Dallas, US). The FDA issued a Cleared decision on January 2, 2021 after a review of 179 days - an extended review cycle.

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 Spark Biomedical, Inc. devices

Submission Details

510(k) Number K201873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2020
Decision Date January 02, 2021
Days to Decision 179 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
31d slower than avg
Panel avg: 148d · This submission: 179d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Regulatory Consultant

Acknowledge Regulatory Strategies, LLC
Michelle Rubin-Onur

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT04075214 Completed Interventional Industry-sponsored

Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal

Delivering Transcutaneous Auricular Neurostimulation (tAN) to Improve Symptoms Associated With Opioid Withdrawal

35
Patients (actual)
1
Site
Treatment
Purpose
Triple
Masking
Condition studied Opioid-use Disorder; Opioid Withdrawal
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Navid Khodaparast, PhD
Sponsor Spark Biomedical, Inc. (industry)
Started 2019-11-19 → Primary completion 2020-12-14
Primary outcome
Clinical opiate withdrawal scale (COWS) score
Secondary outcome
Clinical opiate withdrawal scale (COWS) score
Study completed - no results published. This trial concluded in 2020 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov