# K032526: Binder CO2 Incubator Serie CB

- Pathway: 510(k) (Traditional)
- Applicant: Binder GmbH
- Decided: Aug 29, 2003 after 14 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 K991408 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991408: Forma Scientific Universal Water-Jacketed Incubator, Thermoquest Corp. (1999) Summary page 1.

## Indications for use
Incubators series CB provide suitable growth-conditions for NaHC03 -buffered cell cultures of ova or embryos with controlled temperature at or near 37°C (98.6"F) and carbon-dioxide atmosphere (optional additionally at hyper oxide or hypo oxide atmosphere) at a high humidity. An automatic dry heat decontamination process of the empty incubator, applicable between different loadings assists to avoid contaminations of the cell cultures.

Source page: https://510kreport.com/device/K032526
Methodology: https://510kreport.com/methodology