# K050197: Minitube Temperature Control Unit SC-2000 + 2045

- Pathway: 510(k) (Traditional)
- Applicant: Minitube of America, Inc.
- Decided: Oct 6, 2006 after 617 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Minitube SC-2000 + 2045 temperature control unit is indicated maintaining the temperature of biological material like gametes and embryos at a certain temperature which is essential to cover multiple applications in reproductive medicine, biology and other areas. The only distinguishing feature between the SC-2000 and the SC-2045 is that the inserts on the warming plates of the SC-2045 are at a 45 degree angle from a level horizontal plane, whereas the SC-2000 inserts are vertical to that plane.

Source page: https://510kreport.com/device/K050197
Methodology: https://510kreport.com/methodology