# K980979: Fukuda Denshi Model HC-500 End Tidal CO2 Module

- Pathway: 510(k) (Traditional)
- Applicant: Fukuda Denshi USA, Inc.
- Decided: Jun 12, 1998 after 87 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- 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 K950044 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950044: Fukuda Denshi Model HC-300 End Tidal CO2 Module, Fukuda Denshi USA, Inc. (1995) Summary page 1.

## Indications for use
The Fukuda Denshi model HC-500 End Tidal CO2 Module is indicated in those situation where it is desirable to perform real-time end tidal or inspired carbon dioxide concentration and/or respiration rate monitoring of intubated adult, infant and/or neonate patients who are under the care of a physician, within the confines of a health care facility.

Source page: https://510kreport.com/device/K980979
Methodology: https://510kreport.com/methodology