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The Tracker / October 2026 / K262000

510(k) cleared

Sway System (Sports Plus)

Sway Medical, Inc. · Oct 18, 2026 · K262000

FDA cleared the Sway System (Sports Plus) from Sway Medical, Inc. on Oct 18, 2026 under K262000, a traditional 510(k). The device falls under product code POM, Computerized Cognitive Assessment Aid For Concussion, regulated at 21 CFR 882.1471 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jun 15, 2026. The decision came 125 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Sway Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262000?

K262000 is the FDA 510(k) for Sway System (Sports Plus), submitted by Sway Medical, Inc.. FDA's decision date was Oct 18, 2026, under product code POM (Computerized Cognitive Assessment Aid For Concussion).

Who makes the Sway System (Sports Plus)?

Sway Medical, Inc., based in Tulsa, OK, is the applicant of record for K262000.

How long did the K262000 review take?

FDA received the submission on Jun 15, 2026 and issued its decision on Oct 18, 2026, 125 days later.

← All decisions in October 2026