Cleared Traditional

K260264 - Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON)

K260264 is an FDA 510(k) clearance for Medi Astro Total and Partial Ossicular ..., manufactured by Shanghai Medi Astro Technology Co., Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code ETA cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K260264 · Shanghai Medi Astro Technology Co., Ltd. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
259d
Days
Class 2
Risk

K260264 is an FDA 510(k) clearance for the Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and .... Classified as Replacement, Ossicular Prosthesis, Total (product code ETA), Class II - Special Controls.

Submitted by Shanghai Medi Astro Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on October 14, 2026 after a review of 259 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3495 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K260264

510(k) Number K260264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2026
Decision Date October 14, 2026
Days to Decision 259 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 90d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETA Device Classification - Class 2, Special Controls

Product Code ETA Replacement, Ossicular Prosthesis, Total
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3495
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Consultant

Manton Business and Technology Services
Charles Shen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ETA Replacement, Ossicular Prosthesis, Total

All 39
Devices cleared under the same product code (ETA) and FDA review panel - the closest regulatory comparables to K260264.
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K042503 · Heinz Kurz GmbH Medizintechnik · Oct 2004
K260264 · Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON)
Download PDF FDA Summary Shanghai Medi Astro T…