Thaw-Kit 1

No FDA recalls on record, checked 6 Oct 2026.

Full name

Scandinavian Ivf Sciences Ab, Thaw-Kit 1

510(k) Number

K000618 ↗

FDA Product Code

MQL

Device Class

Class II

Regulation

21 CFR Part 884.6180

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Scandinavian Ivf Sciences Ab, Freeze-Kit 1

  Class II

  FDA 510(k) K000623 Active Cleared 16 May 2000

• Scandinavian Ivf Sciences Ab, G1.2

  Class II

  FDA 510(k) K000625 Active Cleared 23 May 2000

• Scandinavian Ivf Sciences Ab, Gamete-100

  Class II

  FDA 510(k) K000626 Active Cleared 23 May 2000

• Scandinavian Ivf Sciences Ab, Spermrinse -20/100

  Class II

  FDA 510(k) K000621 Active Cleared 16 May 2000

• Hybase-1

  Class II

  FDA 510(k) K000627 Active Cleared 13 Jun 2000

• Scandinavian Ivf Sciences Ab, G2.2

  Class II

  FDA 510(k) K000619 Active Cleared 27 Jun 2000

• What is the Thaw-Kit 1 used for in assisted reproductive technology (ART) procedures?

  The Thaw-Kit 1 is designed specifically for thawing cryopreserved embryos or gametes in ART procedures. It creates a controlled environment that safely and effectively revives frozen biological samples, ensuring they are prepared optimally for subsequent handling, such as transfer or further processing. This minimizes stress on the samples and improves viability.

• Is the Thaw-Kit 1 sterile and how is it supplied?

  Yes, the Thaw-Kit 1 is supplied sterile and packaged individually. This ensures that each device is ready for immediate use in clinical settings, such as fertility clinics, without requiring additional sterilization steps. The sterile packaging helps maintain the integrity of the device until use.

• Is the Thaw-Kit 1 intended for single-use or reuse?

  The Thaw-Kit 1 is explicitly designed for single-use only. This design choice helps prevent cross-contamination between patients and ensures consistent performance and sterility for each thawing procedure. Single-use devices are also aligned with best practices in clinical settings to maintain safety and hygiene.

• Does the Thaw-Kit 1 have any special storage requirements?

  While the device data does not specify exact storage conditions, single-use sterile medical devices like the Thaw-Kit 1 are generally recommended to be stored in a clean, dry environment, protected from direct sunlight, extreme temperatures, and physical damage. It should be kept in its original packaging until use to preserve sterility and functionality.

• What regulatory pathway does the Thaw-Kit 1 follow in the U.S.?

  The Thaw-Kit 1 is regulated under the FDA 510(k) clearance process as a Class II medical device, with a clearance number of K000618. It was determined to be substantially equivalent to a predicate device and falls under regulation 884.6180. This classification ensures it meets specific safety and performance standards for reproductive media used in obstetrics and gynecology applications.