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Accupen

by Accutome Ultrasound, Inc.

510(k) K083377

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK083377 Date27 Jul 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 21 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 Accupen is an ac-powered tonometer designed for use in ophthalmic applications. It functions as a handheld device to measure intraocular pressure.

This device is intended for use by licensed healthcare professionals within the eye care industry. It has received FDA 510K clearance and is classified as a class 2 medical device under regulation number 886.1930.

Other devices from Accutome Ultrasound, Inc.

  • B-Scan Plus

    Class II

  • Accupach V

    Class II

Questions

AI-generated answers, 21 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 primary use of the Accupen?

    The Accupen is an AC-powered tonometer intended for use in ophthalmic applications to measure intraocular pressure. It is designed specifically for use by licensed healthcare professionals within the eye care industry.

  • What is the regulatory status of this device?

    The Accupen has received FDA 510K clearance. It is classified as a class 2 medical device under regulation number 886.1930, which pertains to AC-powered tonometers.

  • Who is authorized to operate the Accupen?

    This device is intended for use exclusively by licensed healthcare professionals. This ensures that the measurement of intraocular pressure is performed by individuals with the appropriate clinical training and expertise.