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Model 30 Classic Pneumatonometer

by Xomed, Inc. 510(k)

Active United States

510(k) K002395

Overview

The Model 30 Classic Pneumatonometer is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced. It is classified as a tonometer and accessories device used in ophthalmic applications.

This device is supplied as a measuring instrument and is not specified as single-use or reusable. It is not indicated as MRI safe. The Model 30 Classic Pneumatonometer received FDA 510(k) clearance with number K002395 on December 11, 2000, and is classified under product code HKX as substantially equivalent.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK002395 Date11 Dec 2000ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
HKX
Device Class
Class II
Regulation
21 CFR Part 886.1930
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Model 30 Classic Pneumatonometer used for?

    The Model 30 Classic Pneumatonometer is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced. It is classified as a tonometer used in ophthalmic applications.

  • Is the Model 30 Classic Pneumatonometer single-use or reusable?

    The Model 30 Classic Pneumatonometer is supplied as a measuring instrument and is not specified as single-use or reusable in the device description. The manufacturer's instructions should be consulted for proper handling and reuse protocols.

  • What regulatory approvals does the Model 30 Classic Pneumatonometer have?

    The Model 30 Classic Pneumatonometer received FDA 510(k) clearance with number K002395 on December 11, 2000, and is classified under product code HKX as substantially equivalent. It is intended for use in ophthalmic applications.

  • Is the Model 30 Classic Pneumatonometer MRI safe?

    The Model 30 Classic Pneumatonometer is not indicated as MRI safe in the device description. Users should consult the manufacturer's instructions for specific information regarding MRI compatibility and safety precautions.