# K082268: CAPNOSTREAM20 with Integrated Pulmonary Index

- Pathway: 510(k) (Traditional)
- Applicant: Oridion Capnography, Inc.
- Decided: Feb 6, 2009 after 179 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K962603 (1997). 36 ancestors in all.
170 later devices descend from it; 3 cite it directly.
2 of 207 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072295: Capnostream 20 with A2 Adaptive Averaging Software, Oridion Capnography, Inc. (2007) Summary page 2.

## Most influential descendants
- 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
- K110516: Connex Vital Signs Monitor 6000 Series (2011), 67 descendants of its own

## Recalls of this device
- Jul 31, 2018 · Class II · Z-0020-2019: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- Jul 31, 2018 · Class II · Z-0028-2019: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- Jul 31, 2018 · Class II · Z-0030-2019: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- Jul 31, 2018 · Class II · Z-0035-2019: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- Jul 31, 2018 · Class II · Z-0024-2019: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- Jul 31, 2018 · Class II · Z-0033-2019: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- Jul 31, 2018 · Class II · Z-0034-2019: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- Jul 31, 2018 · Class II · Z-0029-2019: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- Jul 31, 2018 · Class II · Z-0031-2019: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.

## 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. The Capnostream 20 monitor provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status. The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.

Source page: https://510kreport.com/device/K082268
Methodology: https://510kreport.com/methodology