# K101988: Heal Force CO2 Incubator

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Lishen Scientific Equipment Co., Ltd.
- Decided: Feb 8, 2011 after 209 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: 2 generations back to K002805 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
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) Summary page 1.
- K023465: Kendro Heracell 240 Incubator, Kendro Laboratory Products, L.P. (2003) Summary page 1.

## Indications for use
For Models HF9O, HF240, the intended use of these incubators is to provide an environment with controlled temperature, C02 elevated humidity, and an automatic disinfection mode, for the development of ova or embryos at or near body temperature.

Source page: https://510kreport.com/device/K101988
Methodology: https://510kreport.com/methodology