Skip to content

IVOS Analyzer

by Hamilton Thorne Research

510(k) K920719

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 NumberK920719 Date29 Jun 1992ClearedStatusActive

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  • Withdrawn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
GKL
Device Class
Class II
Regulation
21 CFR Part 864.5200
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 IVOS Analyzer is a Computer Assisted Sperm Analysis (CASA) system designed for the automated assessment of semen quality. It provides accurate measurements of sperm count, concentration, and motility, including classification of velocities, progressive, and static motion.

The device is intended for research use and is supplied as a reusable system. It operates within a hematology specialty and is classified under medical device class 2. Regulatory authorizations include FDA 510(k) clearance.

Other devices from Hamilton Thorne Research

Questions

AI-generated answers, 25 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 IVOS Analyzer used for?

    The IVOS Analyzer is a Computer Assisted Sperm Analysis (CASA) system designed for the automated assessment of semen quality. It provides accurate measurements of sperm count, concentration, and motility, including classification of velocities, progressive, and static motion.

  • Is the IVOS Analyzer a single-use device?

    No, the IVOS Analyzer is supplied as a reusable system.

  • What regulatory authorizations does the IVOS Analyzer have?

    The IVOS Analyzer has FDA 510(k) clearance.

  • What is the device classification for the IVOS Analyzer?

    The IVOS Analyzer is classified under medical device class 2.