# K983642: Cook Mini-Incubator

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ob/Gyn
- Decided: Feb 1, 1999 after 108 days
- Product code: MQG (Accessory, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6120
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 2 cite it directly.
0 of 15 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
- K092183: Embryoscope and Embryoslide (2011), 11 descendants of its own
- K111715: Embryoscope (2011), 9 descendants of its own
- K113075: Embryo Viewer Software (2011), 8 descendants of its own
- K150961: EmbryoSlide Culture Dish (2015), 4 descendants of its own
- K133712: Embryoviewer Software (2014), 4 descendants of its own

## Recalls of this device
- Dec 16, 2020 · Class II · Z-0809-2021: A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause the silicone stoppers to dislodge or gas to leak from the flasks, impeding gas flow to the inc
- Jan 12, 2018 · Class II · Z-1377-2018: The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex lid heater.
- Jan 12, 2018 · Class II · Z-1378-2018: The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex lid heater.

## Indications for use
The COOK Mini-Incubator is intended to be used to store and preserve gametes and/or embryos at or near body temperature.

Source page: https://510kreport.com/device/K983642
Methodology: https://510kreport.com/methodology