PVP (Polyvinylpyrrolidone)

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K991343 ↗

FDA Product Code

MQL

Device Class

Class II

Regulation

21 CFR Part 884.6180

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Human Serum Albumin (Hsa)

  Class II

  FDA 510(k) K983584 Active Cleared 8 Feb 1999

• Continuous Single Culture Complete

  Class II

  FDA 510(k) K121572 Active Cleared 19 Jul 2012

• Oil for Embryo Culture Open recall

  Class II

  FDA 510(k) K011938 Active Cleared 18 Jul 2001

• Htf Medium, Modified Htf Medium- Hepes, Htf Powder (Without Antibiotics), Modified Htg Powder- Hepes (Without Antiboditi

  Class II

  FDA 510(k) K983586 Active Cleared 18 Feb 1999

• Complete Human Tubal Fluid (Htf) with Serum Substitute Supplement, Model 9922

  Class II

  FDA 510(k) K003278 Active Cleared 17 Jan 2001

• Phenol Red Stock Solution

  Class II

  FDA 510(k) K032887 Active Cleared 19 Dec 2003

See all devices from Irvine Scientific Sales Co., Inc. →

• What clinical procedures is this PVP solution specifically designed to support in fertility treatments?

  This PVP solution is designed for sperm preparation and cryopreservation in assisted reproduction procedures. It serves as a medium to preserve and handle reproductive cells, ensuring they remain viable for use in fertility treatments like IVF (in vitro fertilization) or other advanced reproductive technologies.

• Is this PVP solution reusable or intended for single-use only, and how should it be stored?

  The PVP solution is supplied as a sterile, single-use product, meaning each vial is intended for one-time clinical use only. Since it is sterile, it should be stored in a clean, dry environment, protected from light and extreme temperatures, following standard sterile supply chain protocols for reproductive media.

• What regulatory pathway was followed for FDA clearance, and what does this mean for its use in fertility clinics?

  This PVP solution was cleared through the FDA’s 510(k) pathway (K991343) under the classification of reproductive media (Product Code MQL) and falls under the regulatory category 21 CFR 884.6180 for obstetrics/gynecology devices. The clearance indicates it was deemed substantially equivalent to a predicate device, meaning it meets FDA standards for safety and effectiveness in its intended clinical use for sperm preparation and cryopreservation in fertility clinics.

• Are there any specific handling or compatibility considerations for this PVP solution when preparing sperm samples?

  As a synthetic, water-soluble polymer, this PVP solution is designed to be compatible with standard sperm preparation techniques in fertility clinics. Since it is sterile and single-use, it should be handled using aseptic techniques to avoid contamination. No MRI safety concerns are noted, so it can be safely used in clinical settings without interference from magnetic fields.

• How does this PVP solution differ from other reproductive media in terms of its intended use?

  This PVP solution is specifically classified as a reproductive medium under FDA’s Product Code MQL, meaning it is tailored for sperm preparation and cryopreservation. Unlike some other media that may have broader applications, this solution is optimized for preserving and handling sperm cells during assisted reproduction procedures, ensuring compatibility with clinical workflows in fertility clinics.