HYBASE-1
by Vitrolife AB/Scandinavian Ivf Sciences AB 510(k)
Active
510(k) K000627
Overview
The HyBase-1 is a reproductive media device designed for use in assisted reproductive technology (ART) procedures. It serves as a culture system for gametes and embryos, providing a controlled environment to support fertilization and early embryonic development.
This device is intended for single-use in clinical settings, including fertility clinics and IVF laboratories. It is classified as a Class II medical device under FDA regulations (884.6180) and has received a Traditional 510(k) clearance from the FDA. The HyBase-1 is supplied sterile and requires no additional sterilization before use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK000627 | Date13 Jun 2000 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Full name
- Scandinavian Ivf Sciences Ab, Hybase-1
- 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
Other devices from Vitrolife AB/Scandinavian Ivf Sciences AB
Questions
What is the HyBase-1 primarily used for in clinical settings?
The HyBase-1 is designed as a culture system for gametes and embryos within assisted reproductive technology (ART) procedures. It provides a controlled environment to support fertilization and the early development of embryos, making it essential for fertility clinics and IVF laboratories.
Is the HyBase-1 intended for single-use or repeated use in a clinical setting?
The HyBase-1 is explicitly intended for single-use only. This design ensures sterility and safety for each procedure, eliminating the need for additional sterilization before use.
How is the HyBase-1 supplied, and does it require any preparation before use?
The HyBase-1 is supplied sterile, meaning no further sterilization is required before clinical use. This simplifies setup and reduces the risk of contamination in the lab environment.
What regulatory pathway was followed for the HyBase-1’s clearance, and which committee reviewed it?
The HyBase-1 received a Traditional 510(k) clearance from the FDA, which means it was determined to be substantially equivalent to a legally marketed predicate device. The Obstetrics/Gynecology (OB) advisory committee reviewed the submission during this process.
Are there multiple sizes or models of the HyBase-1, or is it available in a single configuration?
The provided data does not specify distinct sizes or models beyond its classification as a reproductive media device for gametes and embryos. However, the registration numbers suggest multiple lot or batch variations may exist, but these do not imply different physical configurations.