Cleared Traditional

K241737 - Sway System Sports Plus (FDA 510(k) Clearance)

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

K241737 · Sway Medical, Inc. · Neurology device
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Feb 2025
Decision
243d
Days
Class 2
Risk

K241737 is an FDA 510(k) clearance for the Sway System Sports Plus. Classified as Computerized Cognitive Assessment Aid For Concussion (product code POM), Class II - Special Controls.

Submitted by Sway Medical, Inc. (Tulsa, US). The FDA issued a Cleared decision on February 15, 2025 after a review of 243 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1471 - 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 Sway Medical, Inc. devices

Submission Details

510(k) Number K241737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2024
Decision Date February 15, 2025
Days to Decision 243 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
95d slower than avg
Panel avg: 148d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code POM Computerized Cognitive Assessment Aid For Concussion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1471
Definition For Use As An Assessment Aid In The Management Of Concussion.
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 Consultant

Steurer Consulting Group, LLC
Robert Steurer

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.