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SperSort Sperm Sorting Chip (IPG02)

by Ipreg Incorporation

510(k) K241626

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK241626 Date20 Feb 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 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  • Withdrawn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
MQK
Device Class
Class II
Regulation
21 CFR Part 884.6160
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The SperSort Sperm Sorting Chip (IPG02) is a microfluidic-based labware device designed for assisted reproduction. It enables the separation of highly motile, morphologically normal sperm from unprocessed semen without centrifugation, preserving sperm DNA integrity during the preparation process.

This single-use, radiation-sterilized device consists of an upper collection chamber and a lower semen sample chamber, separated by a porous filter. It is intended for use in clinical settings, adhering to FDA 510(k) clearance under the classification of Class 2 Obstetrics & Gynecology labware. The device requires 1.9 mL of liquefied semen in the lower chamber and 1.5 mL of sperm washing medium in the upper chamber for operation.

Questions

AI-generated answers, 1 Oct 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 SperSort Sperm Sorting Chip (IPG02) used for?

    The SperSort Sperm Sorting Chip (IPG02) is a microfluidic-based labware device designed specifically for assisted reproduction. It enables the separation of highly motile and morphologically normal sperm from unprocessed semen without the need for centrifugation. This process helps preserve sperm DNA integrity, which is critical for improving the success rates of fertility treatments.

  • How is the SperSort Sperm Sorting Chip (IPG02) supplied and prepared for use?

    The device is supplied as a single-use, radiation-sterilized unit. To prepare it for use, you place 1.9 mL of liquefied semen in the lower chamber and 1.5 mL of sperm washing medium in the upper collection chamber. The porous filter between the chambers facilitates the separation of sperm without centrifugation.

  • Is the SperSort Sperm Sorting Chip (IPG02) reusable or single-use?

    The SperSort Sperm Sorting Chip (IPG02) is explicitly designed for single-use only. This ensures sterility and prevents cross-contamination between patients, aligning with clinical best practices for assisted reproduction procedures.

  • What sizes or models of the SperSort Sperm Sorting Chip (IPG02) are available?

    The SperSort Sperm Sorting Chip (IPG02) is available in a standardized design with fixed chamber volumes (1.9 mL semen chamber and 1.5 mL washing medium chamber). No additional sizes or models are specified in the device documentation.

  • How should the SperSort Sperm Sorting Chip (IPG02) be stored before use?

    The device should be stored in a clean, dry environment protected from direct light and extreme temperatures. Since it is radiation-sterilized, it should remain in its sealed packaging until immediately before use to maintain sterility and functionality.