Enhance Sperm Freeze

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K030117 ↗

FDA Product Code

MQL

Device Class

Class II

Regulation

21 CFR Part 884.6180

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Enhance-S Plus

  Class II

  FDA 510(k) K991322 Active Cleared 26 Jul 1999

• Enhance-S Plus H

  Class II

  FDA 510(k) K030116 Active Cleared 12 Feb 2003

• Microtools

  Class II

  FDA 510(k) K991104 Active Cleared 19 Jul 1999

• Ovulon Monitor

  Class I

  FDA 510(k) K973860 Active Cleared 7 Jan 1998

• What is Enhance Sperm Freeze used for?

  Enhance Sperm Freeze is a HEPES-buffered freezing medium specifically designed for cryopreserving human sperm. It creates a protective environment to minimize damage during freezing, ensuring sperm remain viable for use in assisted reproductive procedures like IVF or IUI. The inclusion of 0.4% human serum albumin (tested negative for HIV and Hepatitis) further safeguards sperm integrity during storage.

• How is Enhance Sperm Freeze supplied, and what sizes are available?

  This device is supplied in sterile, single-use containers to maintain sterility and prevent contamination. Two sizes are available: a 20 mL container (Reference #15609) and a larger 100 mL container (Reference #15765). The choice of size depends on the volume of sperm being cryopreserved in a given clinical setting.

• Is Enhance Sperm Freeze intended for single-use or reuse?

  Enhance Sperm Freeze is explicitly designed for single-use only. The sterile packaging ensures safety and efficacy for one procedure, preventing cross-contamination between patients. Reusing the medium could compromise sterility and the protective properties of the formulation, risking sperm damage or contamination.

• What storage and handling guidelines should be followed for Enhance Sperm Freeze?

  Storage and handling follow standard sterile media protocols. The medium should be stored under refrigeration (2–8°C) until use, as per typical practices for cryopreservation media. Once thawed or opened, it should be used immediately to avoid degradation. Avoid exposure to extreme temperatures or direct light, and adhere to clinical fertility lab protocols for contamination control.

• Does Enhance Sperm Freeze require any special regulatory compliance beyond its FDA clearance?

  Beyond its FDA 510(k) clearance (K030117) under the Reproductive Media and Supplements regulation (21 CFR 884.6180), this device complies with standard sterile media handling and storage protocols. No additional regulatory considerations like MRI safety are specified, as it is a consumable medium used in clinical fertility settings. Always follow local facility protocols for reproductive media.