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# Revoke Eye-Sync 510(k) Indication: Pink Concussions
- URL: https://www.fdaweb.com/revoke-eye-sync-510-k-indication-pink-concussions/
- Published: 2022-03-01T12:00:00.000Z
- Updated: 2026-09-14T17:34:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151261

Pink Concussions founder and CEO **Katherine Snedaker**, a social worker,is asking FDA to revoke the 510(k) clearance indication for use for the SyncThink Eye-Sync as an aid in diagnosing concussion. A 2/26 [petition](https://downloads.regulations.gov/FDA-2022-P-0234-0001/attachment%5F1.pdf?ref=fdaweb.com) says the Eye-Sync product does not provide any addition to sensitivity or specificity for assessing concussion to the self-reported concussion symptom checklist that it is required to be used with. The petition cites several reasons why the device “does not provide additive value beyond a symptom checklist” and thus its clearance is “not in the public interest.”

Pink Concussions says it is the “first ever non-profit organization to focus on pre-injury education and post-injury medical care for women and girls with brain injury including concussion incurred from sport, violence, accidents, or military service.”