# K021042: Thermo Forma, Cryomed, Controlled Rate Freezers; Models # 7456, 7457, 7458,7459,7475,7476

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Forma, Inc.
- Decided: May 15, 2002 after 44 days
- Product code: MQG (Accessory, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The intended use of these freezers is to freeze gametes and/or embryos. The functionality of a controlled rate freezer is designed to allow the user to select the desired cooling rate and temperature, for the purpose of improved viability.

Source page: https://510kreport.com/device/K021042
Methodology: https://510kreport.com/methodology