# K991408: Forma Scientific Universal Water-Jacketed Incubator

- Pathway: 510(k) (Traditional)
- Applicant: Thermoquest Corp.
- Decided: Jul 19, 1999 after 88 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K032526: Binder CO2 Incubator Serie CB (2003), 0 descendants of its own

## Indications for use
The intended use of these incubators is to provide an environment with controlled temperature, CO, and an elevated humidity, for the development of ova or embryos. Certain models also control O, at suppressed levels.

Source page: https://510kreport.com/device/K991408
Methodology: https://510kreport.com/methodology