# K101995: Capnostream 20P with Masimo SPO2 Board

- Pathway: 510(k) (Traditional)
- Applicant: Oridion Capnography, Inc.
- Decided: Jan 11, 2011 after 181 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: 12 generations back to K962603 (1997). 47 ancestors in all.
7 later devices descend from it; 1 cites it directly.
2 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K094012: CAPNOSTREAM20 with MICROMEDICO2 Module, Oridion Capnography, Inc. (2010) Summary page 2.
- K080238: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse CO-Oximeter, Masimo Corporation (2008) Summary page 2.

## Most influential descendants
- K112368: CAPNOSTREAM20P with AI/Odi (2012), 6 descendants of its own
- K150272: Capnostream 35 Portable Respiratory Monitor (2015), 4 descendants of its own
- K200594: Capnostream 35 Portable Respiratory Monitor (2020), 1 descendant of its own
- K253030: Capnostream™35 Portable Respiratory Monitor (PM35MN) (2026), 0 descendants of its own
- K213911: Microstream CO2 NanoPod (2022), 0 descendants of its own

## Indications for use
The Capnostream@20p combined capnograph/pulse oximeter monitor and its accessories are intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and with continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is also indicated for continuous non-invasive monitoring of carboxyhemoglobin saturation (measured by an SpCO/SpMetISpHb sensor), methemoglobin saturation (measured by an SpCO/SpMetISpHb sensor) and total hemoglobin concentration (measured by an SpCO/SpMetISpHb sensor). It is intended for use with neonatal, pediatric, and adult patients in hospitals, hospital-type facilities, intra-hospital transport and home environments. The Capnostream@020p monitor provides the clinician with an integrated pulmonary index (IPI). The IP1 is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IP1 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. IP1 monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status. The IP1 is an adjunct to, and is not intended to replace, vital sign monitoring.

Source page: https://510kreport.com/device/K101995
Methodology: https://510kreport.com/methodology