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Pureception Lower Phase, Pureception Upper Phase, Pureception with Hepes-Buffered Ham's F-10 and Hsa

by Pacific Andrology, Inc.

510(k) K991381

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK991381 Date24 Sep 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
MQL
Device Class
Class II
Regulation
21 CFR Part 884.6180
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

This device is a density gradient media system comprising Lower Phase, Upper Phase, and Sperm Washing Media. It is formulated with HEPES-buffered Ham's F-10 and Human Serum Albumin (HSA).

It is supplied as a sterile colloidal suspension for sperm preparation by the density gradient method. The device is intended for use in reproductive medicine settings and is authorized under FDA 510(k) clearance K991381, classified as Media, Reproductive (product code MQL), Class II with special controls.

Other devices from Pacific Andrology, Inc.

Questions

AI-generated answers, 27 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 Pureception used for?

    Pureception is intended for sperm preparation by the density gradient method in reproductive medicine settings, using its Lower Phase, Upper Phase, and Sperm Washing Media components to isolate motile spermatozoa from semen samples.

  • How is Pureception supplied and what is its sterility status?

    Pureception is supplied as a sterile colloidal suspension, ensuring it is free from microbial contamination and ready for use in assisted reproductive procedures without additional sterilization steps.

  • What are the key components of Pureception media?

    Pureception is formulated with HEPES-buffered Ham's F-10 and Human Serum Albumin (HSA), which together create a density gradient environment that supports sperm viability and function during preparation.

  • Is Pureception reusable or single-use?

    Pureception is designed for single-use only; reusing the media risks contamination, loss of gradient integrity, and compromised sperm quality, which could affect clinical outcomes in reproductive procedures.