Cleared Traditional

K262000 - Sway System (Sports Plus)

K262000 is an FDA 510(k) clearance for Sway System (Sports Plus), manufactured by Sway Medical, Inc.. The device is a Class 2 Neurology device with product code POM cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K262000 · Sway Medical, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
125d
Days
Class 2
Risk

K262000 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 October 18, 2026 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 882.1471 - 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.

FDA 510(k) Submission Details - K262000

510(k) Number K262000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2026
Decision Date October 18, 2026
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
24d faster than avg
Panel avg: 149d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

POM Device Classification - Class 2, Special Controls

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 Peers - POM Computerized Cognitive Assessment Aid For Concussion

All 8
Devices cleared under the same product code (POM) and FDA review panel - the closest regulatory comparables to K262000.
Sway System Sports Plus
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K262000 · Sway System (Sports Plus)
Download PDF FDA Summary Sway Medical, Inc.