# K023465: Kendro Heracell 240 Incubator

- Pathway: 510(k) (Traditional)
- Applicant: Kendro Laboratory Products, L.P.
- Decided: Mar 10, 2003 after 146 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 K002805 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002805: Kendro Heracell CO2 Incubator, Kendro Laboratory Products, L.P. (2000). Our reading of the summary gave K002505, FDA’s number for Xia Spine System (Howmedica Osteonics Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Kendro HEMcell CO2 Incubator”.

## Most influential descendants
- K101988: Heal Force CO2 Incubator (2011), 0 descendants of its own

## Indications for use
The intended use of this incubator is to provide an environment with controlled temperature, CO2, elevated humidity, an automatic decontamination mode, and O2 at suppressed levels, for the development of ova or embryos at or near body temperature.

Source page: https://510kreport.com/device/K023465
Methodology: https://510kreport.com/methodology