An independent, FDA-recognized 3P510k Review Organization under the U.S. FDA CDRH 510(k) Third Party Review Program.
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Review experience.

Objective, FDA-sourced records of completed reviews once public, and current engagements shown only with written sponsor permission.

Public review records

Once a sponsor's 510(k) becomes public in FDA's 510(k) database, GTPR publishes objective, FDA-sourced records here — with a direct link to the official FDA record. GTPR does not publish recommendations, deficiency details or confidential submission information.

Objective records drawn from FDA's 510(k) database.
SponsorDeviceProduct codeFDA 510(k) recordFDA decision
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Active engagements

Organizations shown below are current sponsors displayed with written permission. Nothing here indicates a regulatory outcome.

SYLKESponsor — shown with permission.
HMD — Hindustan Medical DevicesSponsor — shown with permission.
Important: Identification of an organization or engagement does not indicate FDA clearance, GTPR endorsement or a favorable regulatory determination.