Cleared Traditional

K170902 - Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit (FDA 510(k) Clearance)

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

K170902 · Spr Therapeutics, LLC · Neurology device
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Jun 2017
Decision
90d
Days
Class 2
Risk

K170902 is an FDA 510(k) clearance for the Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Proced.... Classified as Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief (product code NHI), Class II - Special Controls.

Submitted by Spr Therapeutics, LLC (Cleveland, US). The FDA issued a Cleared decision on June 26, 2017 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 882.5890 - 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 Spr Therapeutics, LLC devices

Submission Details

510(k) Number K170902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2017
Decision Date June 26, 2017
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHI Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Percutaneous Electrical Nerve Stimulator (pens) Is A Device Used For The Treatment Of Pain. Unlike The Classified Transcutaneous Electrical Nerve Stimulator That Apply An Electrical Current To Electrodes On A Patient's Skin To Deliver Stimulation, A Pens Uses Electrodes That Are Placed Percutaneously To Deliver Stimulation,
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 - NHI Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief

All 12
Devices cleared under the same product code (NHI) and FDA review panel - the closest regulatory comparables to K170902.
SPRINT Peripheral Nerve Stimulation (PNS) System
K223306 · Spr Therapeutics, Inc. · Jan 2023
Primary Relief
K221425 · Dyansys, Inc. · Sep 2022
ANSiStim-PP
K220397 · Dyansys, Inc. · May 2022
Primary Relief
K213188 · Dyansys, Inc. · Jan 2022
First Relief
K212859 · Dyansys, Inc. · Dec 2021
SPRINT PNS System
K211801 · Spr Therapeutics, Inc. · Oct 2021