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The Tracker / October 2026 / K260264

510(k) cleared

Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON)

Shanghai Medi Astro Technology Co., Ltd. · Oct 14, 2026 · K260264

FDA cleared the Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) from Shanghai Medi Astro Technology Co., Ltd. on Oct 14, 2026 under K260264, a traditional 510(k). The device falls under product code ETA, Replacement, Ossicular Prosthesis, Total, regulated at 21 CFR 874.3495 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 259 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 Shanghai Medi Astro Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260264?

K260264 is the FDA 510(k) for Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON), submitted by Shanghai Medi Astro Technology Co., Ltd.. FDA's decision date was Oct 14, 2026, under product code ETA (Replacement, Ossicular Prosthesis, Total).

Who makes the Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON)?

Shanghai Medi Astro Technology Co., Ltd., based in Shanghai, is the applicant of record for K260264.

How long did the K260264 review take?

FDA received the submission on Jan 28, 2026 and issued its decision on Oct 14, 2026, 259 days later.

← All decisions in October 2026