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Eckhardt Temporary Keratoprosthesis

by Dutch Ophthalmic USA, Inc. 510(k)

Active United States

510(k) K902491

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK902491 Date26 Jun 1990ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MLP
Device Class
Class II
Regulation
21 CFR Part 886.3400
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Eckhardt Temporary Keratoprosthesis is a temporary implant of surgical use intended for ophthalmic procedures. It is designed to be placed during combined corneal and vitreoretinal surgeries to provide a clear surgical view of the posterior segment in eyes with concurrent corneal pathology. The device is composed of optically clear silicone.

The device is supplied by Dutch Ophthalmic USA, Inc. and is regulated under product code MLP, with a device class of 2. It is a single-use device intended for surgical settings and is registered under the FDA 510(k) premarket notification with k-number K902491. The device is not intended for long-term implantation and is used temporarily during surgery.

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Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Eckhardt Temporary Keratoprosthesis used for?

    It is a temporary implant used during combined corneal and vitreoretinal surgeries to provide a clear surgical view of the posterior segment in eyes that also have corneal pathology. It is not intended for long-term implantation.

  • How is the device supplied and is it sterile?

    The device is supplied by Dutch Ophthalmic USA, Inc. as a single-use device intended for surgical settings. While the data confirms single-use status and surgical intent, specific sterility claims or packaging details are not provided in the source information.

  • Is this device reusable or single-use?

    The Eckhardt Temporary Keratoprosthesis is strictly a single-use device. It is designed for temporary use during a surgical procedure and must be discarded after the operation.

  • What material is the device made from?

    The device is composed of optically clear silicone, which allows for a clear view of the posterior segment during surgery.

  • What is the regulatory classification of this device?

    It is a Class 2 device under product code MLP, regulated under the FDA 510(k) premarket notification pathway. It was determined to be substantially equivalent to a predicate device under k-number K902491.