# K992116: Siememns Infinity ETC02 Pod

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jan 12, 2000 after 204 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 K954632 (1996). 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)
- K954632: Siemens SC 9000 ETCO2 Module, Siemens Medical Solutions USA, Inc. (1996) Summary page 1.
- K963380: CO 2 Smo Plus, Novametrix Medical Systems, Inc. (1997) Summary page 1.

## Indications for use
Siemens INFINITY etCO2 is indicated for use in the adult, pediatric and neonatal populations, in an environment where patient care is provided by healthcare professionals, i.e. Physicians, Nurses, Technicians, when the professional determines that the device is required to measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode (side-stream mode is not intended for use in the neonatal patient population). In conjunction with the SC 7000 / SC 8000 / SC 9000XL monitors, visual and audible alarms will be produced if any of these parameters vary beyond preset limits, and timed or alarm recordings will be produced.

Source page: https://510kreport.com/device/K992116
Methodology: https://510kreport.com/methodology