Cleared Traditional

K230796 - Sparrow Ascent (FDA 510(k) Clearance)

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

K230796 · Spark Biomedical, Inc. · Neurology device
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Jun 2023
Decision
90d
Days
Class 2
Risk

K230796 is an FDA 510(k) clearance for the Sparrow Ascent. 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 June 20, 2023 after a review of 90 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 Spark Biomedical, Inc. devices

Submission Details

510(k) Number K230796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2023
Decision Date June 20, 2023
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
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 Consultant

RQM+
Allison Komiyama

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.

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 K230796.
Sparrow Ascent
K251246 · Spark Biomedical, Inc. · Aug 2025
NET Recovery Corp/NET Device
K233166 · Net Recovery · May 2024
Drug Relief v1
K221231 · Dyansys, Inc. · Jun 2022
Drug Relief v1
K211971 · Dyansys, Inc. · Nov 2021
Sparrow Therapy System
K201873 · Spark Biomedical, Inc. · Jan 2021