Cleared Traditional

K161154 - Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs (FDA 510(k) Clearance)

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

K161154 · Spr Therapeutics, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
89d
Days
Class 2
Risk

K161154 is an FDA 510(k) clearance for the Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, an.... 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 July 23, 2016 after a review of 89 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Spr Therapeutics, LLC devices

Submission Details

510(k) Number K161154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2016
Decision Date July 23, 2016
Days to Decision 89 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
59d faster than avg
Panel avg: 148d · This submission: 89d
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 K161154.
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