Cleared Traditional

K251821 - ARC-EX System

K251821 is an FDA 510(k) clearance for ARC-EX System, manufactured by Onward Medical, Inc.. The device is a Class 2 Neurology device with product code SDO cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K251821 · Onward Medical, Inc. · Neurology device
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Nov 2025
Decision
154d
Days
Class 2
Risk

K251821 is an FDA 510(k) clearance for the ARC-EX System. Classified as Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation (product code SDO), Class II - Special Controls.

Submitted by Onward Medical, Inc. (Boston, US). The FDA issued a Cleared decision on November 14, 2025 after a review of 154 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.5851 - 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 Onward Medical, Inc. devices

FDA 510(k) Submission Details - K251821

510(k) Number K251821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2025
Decision Date November 14, 2025
Days to Decision 154 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
6d slower than avg
Panel avg: 148d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

SDO Device Classification - Class 2, Special Controls

Product Code SDO Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5851
Definition A Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation Is A Device That Can Be Programmed To Apply An Electrical Current Via Electrodes On A Patient's Skin Over The Spine To Improve Muscle Strength And Sensation After Neurological Deficit.
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.