# K013703: Sanyo CO2 Incubators, Models Nos. Mco-17AC, Mco-17AIC, Mco-20AIC,and MC0-175M

- Pathway: 510(k) (Traditional)
- Applicant: Sanyo North America Corp.
- Decided: Dec 14, 2001 after 36 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
Longest line of descent: 1 generation back to K001524 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001524: Forma Scientific Direct Heat Incubators, Thermoquest Corp. (2000) Summary page 1.
- K002805: Kendro Heracell CO2 Incubator, Kendro Laboratory Products, L.P. (2000) Summary page 1.

## Indications for use
To provide an environment with controlled temperature, CO;, (and other gases), and elevated humidity for the development of ova or embryos.

Source page: https://510kreport.com/device/K013703
Methodology: https://510kreport.com/methodology