# K983609: Cook Test Tube Heater

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ob/Gyn
- Decided: Dec 16, 1998 after 63 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 COOK Test Tube Heater is intended to be used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. The unit is designed to accept up to six Falcon® 2001 Series 10 mL test tubes.

Source page: https://510kreport.com/device/K983609
Methodology: https://510kreport.com/methodology