# K112368: CAPNOSTREAM20P with AI/Odi

- Pathway: 510(k) (Traditional)
- Applicant: Oridion Medical 1987, Ltd.
- Decided: Jul 19, 2012 after 337 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K962603 (1997). 48 ancestors in all.
6 later devices descend from it; 2 cite 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)
- K101995: Capnostream 20P with Masimo SPO2 Board, Oridion Capnography, Inc. (2011) Summary page 2.
- (no number) Capnostream2Op with Masimo MX1 SpO2 board: named in the summary without a submission number

## Most influential descendants
- 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
- K213518: CARESCAPE CO2 Microstream parameter (2022), 0 descendants of its own

## Recalls of this device
- Jul 31, 2018 · Class II · Z-0022-2019: 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-0023-2019: 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-0026-2019: 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-0027-2019: 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-0025-2019: 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-0021-2019: 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®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 non-invasive 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®20p 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 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/K112368
Methodology: https://510kreport.com/methodology