Cleared Traditional

K211801 - SPRINT PNS System (FDA 510(k) Clearance)

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

K211801 · Spr Therapeutics, Inc. · Neurology device
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Oct 2021
Decision
125d
Days
Class 2
Risk

K211801 is an FDA 510(k) clearance for the SPRINT PNS System. Classified as Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief (product code NHI), Class II - Special Controls.

Submitted by Spr Therapeutics, Inc. (Cleveland, US). The FDA issued a Cleared decision on October 13, 2021 after a review of 125 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, Inc. devices

Submission Details

510(k) Number K211801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2021
Decision Date October 13, 2021
Days to Decision 125 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
23d faster than avg
Panel avg: 148d · This submission: 125d
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 K211801.
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
K202660 · Spr Therapeutics, Inc. · Jan 2021