Cleared Traditional

K220177 - Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K (FDA 510(k) Clearance)

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

K220177 · Magnus Medical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2022
Decision
223d
Days
Class 2
Risk

K220177 is an FDA 510(k) clearance for the Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K. Classified as Transcranial Magnetic Stimulator (product code OBP), Class II - Special Controls.

Submitted by Magnus Medical, Inc. (Burlingame, US). The FDA issued a Cleared decision on September 1, 2022 after a review of 223 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5805 - 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 Magnus Medical, Inc. devices

Submission Details

510(k) Number K220177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2022
Decision Date September 01, 2022
Days to Decision 223 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
75d slower than avg
Panel avg: 148d · This submission: 223d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OBP Transcranial Magnetic Stimulator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5805
Definition A Transcranial Magnetic Stimulator Is A Device That Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields To Induce Electrical Currents That Are Directed At Spatially Discrete Regions Of The Cerebral Cortex For The Treatment Of Major Depressive Disorder.
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.

Clinical Evidence

ClinicalTrials.gov
NCT03068715 Completed Interventional

Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression (SAINT-TRD)

30
Patients (actual)
1
Site
Treatment
Purpose
Quadruple
Masking
Condition studied Treatment Resistant Depression
Study design Parallel
Eligibility All sexes · 22 Years+
Principal investigator Nolan Williams, MD
Sponsor Stanford University
Started 2017-03-20 → Primary completion 2020-01-25 → Completed 2021-01-09
Primary outcome
Percentage Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score From Pre-treatment to 1-month Post-treatment.
Secondary outcome
Percentage Change in the Hamilton Rating Scale for Depression (HAMD-17)
View full study on ClinicalTrials.gov

Regulatory Peers - OBP Transcranial Magnetic Stimulator

All 63
Devices cleared under the same product code (OBP) and FDA review panel - the closest regulatory comparables to K220177.
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
K252358 · Nexstim Oyj · Mar 2026
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
K253098 · Nexstim Oyj · Mar 2026
SPRY TMS Therapy System (0550)
K251653 · Soterix Medical, Inc. · Feb 2026
BrainsWay Deep TMS System
K251391 · Brainsway , Ltd. · Nov 2025
CloudTMS Edge
K250689 · Teleemg, LLC · Sep 2025
BrainsWay Deep TMS System
K251449 · Brainsway , Ltd. · Sep 2025