Thermo Forma CryoMed Controlled Rate Freezers Models 7456, 7457, 7458, 7459, 7475, 7476
510(k) K021042
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK021042 | Date15 May 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MQG
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.6120
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Thermo Forma CryoMed Controlled Rate Freezers are classified as accessories for assisted reproduction, designed to facilitate the controlled freezing of biological samples at cryogenic temperatures. These devices provide precise temperature regulation to preserve cellular integrity during the transition to ultra-low storage conditions, typically below -130°C. Their primary function is to ensure gradual cooling rates, minimizing ice crystal formation and damage to stored samples. This is critical for applications in fertility preservation, embryo cryopreservation, and other medical sample storage protocols.
These freezers are intended for use in clinical or laboratory settings, where they are supplied as reusable medical devices. They are not sterile upon delivery and require cleaning and maintenance as per manufacturer guidelines. The devices are MRI-safe and comply with regulatory standards under FDA 510(k) clearance (K021042) for Class II devices. Models 7456, 7457, 7458, 7459, 7475, and 7476 are designed for controlled-rate freezing with programmable protocols, including preset and user-defined freezing cycles. Storage and operation must adhere to manufacturer instructions to ensure optimal performance and sample viability.
Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of the CryoMed Controlled Rate Freezers?
The CryoMed Controlled Rate Freezers are designed to facilitate the controlled freezing of biological samples, such as embryos or reproductive cells, at cryogenic temperatures. Their key function is to provide precise temperature regulation during the freezing process, ensuring gradual cooling rates to minimize ice crystal formation and preserve cellular integrity. This is critical for applications in fertility preservation and embryo cryopreservation, where sample viability is essential for successful outcomes.
Are these freezers reusable or single-use?
The CryoMed Controlled Rate Freezers are reusable medical devices. They are not supplied sterile and require cleaning and maintenance as outlined in the manufacturer’s guidelines to ensure optimal performance and longevity. Reusability is a key feature for clinical and laboratory settings where cost-effectiveness and consistent operation are priorities.
What temperature range do these freezers operate within?
These freezers are designed to operate at cryogenic temperatures, specifically to achieve and maintain storage conditions below -130°C. The controlled-rate freezing process gradually cools samples to preserve their structural integrity, reducing damage from rapid freezing. This temperature range is essential for long-term storage of biological samples like embryos or sperm.
Which models are included in the CryoMed Controlled Rate Freezers series?
The series includes models 7456, 7457, 7458, 7459, 7475, and 7476. Each model is equipped with programmable protocols, including preset and user-defined freezing cycles, to accommodate various clinical or laboratory freezing requirements. The specific model chosen may depend on factors like chamber size, cooling capacity, or additional features such as automated controls.
Are these freezers MRI-safe, and how does that affect their use?
Yes, the CryoMed Controlled Rate Freezers are MRI-safe. This means they can be used in environments where MRI machines are present without interfering with imaging or posing risks to patients or equipment. MRI safety is particularly important in clinical settings where these freezers may be located near diagnostic imaging areas, ensuring seamless integration into workflows without compromising safety or functionality.