# K072295: Capnostream 20 with A2 Adaptive Averaging Software

- Pathway: 510(k) (Special)
- Applicant: Oridion Capnography, Inc.
- Decided: Oct 11, 2007 after 56 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K962603 (1997). 35 ancestors in all.
197 later devices descend from it; 3 cite it directly.
2 of 233 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060065: CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor, Oridion Capnography, Inc. (2006) Summary page 2.

## Most influential descendants
- K082268: CAPNOSTREAM20 with Integrated Pulmonary Index (2009), 170 descendants of its own
- K091241: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter (2009), 155 descendants of its own
- K100428: Masimo Rainbow Set Radical 7R Pulse CO-Oximeter (2010), 115 descendants of its own
- K094012: CAPNOSTREAM20 with MICROMEDICO2 Module (2010), 93 descendants of its own
- K110028: Masimo Radical Y Pulse CO-Oximeter (2011), 89 descendants of its own

## Indications for use
The Capnostream 20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2 and pulse rate). It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital transport and home environments.

Source page: https://510kreport.com/device/K072295
Methodology: https://510kreport.com/methodology