ISM1+, IMS2+, and Utm+

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

510(k) Number

K030490 ↗

FDA Product Code

MQL

Device Class

Class II

Regulation

21 CFR Part 884.6180

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Embryoassist

  Class II

  FDA 510(k) K061309 Active Cleared 8 Feb 2007

• Medi-Cult Freezing & Thawing Packs

  Class II

  FDA 510(k) K991335 Active Cleared 28 Feb 2000

• Medi-Cult Acidified Tyrodes Solution- Medium; Internal Catalog Numbers (1060)

  Class II

  FDA 510(k) K991470 Active Cleared 7 Mar 2000

• Synvitro Flush

  Class II

  FDA 510(k) K003163 Active Cleared 22 Mar 2001

• Blastfreeze and Blastthaw

  Class II

  FDA 510(k) K031486 Active Cleared 27 Jun 2003

• Suprasperm System

  Class II

  FDA 510(k) K003404 Active Cleared 22 Mar 2001

See all devices from Medicult A/S →

• What is the purpose of the ISM1+, IMS2+, and UTM+ system?

  The ISM1+, IMS2+, and UTM+ system is a specialized culture media system designed for in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) procedures. ISM1+ supports post-fertilization embryo development up to the 6- to 8-cell stage (Day 3), ISM2+ facilitates extended culture from the 6- to 8-cell stage to the blastocyst stage (Day 5), and UTM+ serves as the transfer medium for embryo transfer procedures.

• How is the ISM1+, IMS2+, and UTM+ system supplied and what is its sterility status?

  The ISM1+, IMS2+, and UTM+ system is supplied as a sterile product for single-use in clinical settings. It is designed for sequential use in the IVF and ICSI process, ensuring optimal conditions for embryo development and transfer.

• What is the regulatory status of the ISM1+, IMS2+, and UTM+ system?

  The ISM1+, IMS2+, and UTM+ system is regulated under FDA 510(k) clearance with product code MQL. It is intended for use in obstetrics and gynecology procedures and has been determined to be substantially equivalent to predicate devices.

• Are there different sizes or models available for the ISM1+, IMS2+, and UTM+ system?

  The ISM1+, IMS2+, and UTM+ system consists of three distinct media components designed for sequential use in the IVF and ICSI process. While the description doesn't specify different sizes or models, each component serves a specific purpose in the embryo development and transfer workflow.