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The Tracker / August 2026 / K260266

510(k) cleared

Tympendi (810)

Grace Medical, Inc. · Aug 18, 2026 · K260266

FDA cleared the Tympendi (810) from Grace Medical, Inc. on Aug 18, 2026 under K260266, a traditional 510(k). The device falls under product code KHJ, Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material), regulated at 21 CFR 874.3620 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Jan 28, 2026. The decision came 202 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 Grace Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260266?

K260266 is the FDA 510(k) for Tympendi (810), submitted by Grace Medical, Inc.. FDA's decision date was Aug 18, 2026, under product code KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)).

Who makes the Tympendi (810)?

Grace Medical, Inc., based in Memphis, TN, is the applicant of record for K260266.

How long did the K260266 review take?

FDA received the submission on Jan 28, 2026 and issued its decision on Aug 18, 2026, 202 days later.

← All decisions in August 2026