# K150272: Capnostream 35 Portable Respiratory Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Oridion Medical 1987, Ltd.
- Decided: Jul 17, 2015 after 163 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K962603 (1997). 69 ancestors in all.
4 later devices descend from it; 3 cite it directly.
1 of 74 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112368: CAPNOSTREAM20P with AI/Odi, Oridion Medical 1987, Ltd. (2012) Summary page 5.
- K130320: Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring System with Respiration Rate Softw, Covidien (2014) Summary page 5.

## Most influential descendants
- 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
- Nov 16, 2020 · Class II · Z-0515-2021: The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of a false display of the message, "Temperature Exceeds Limits" followed by automatic shutdown

## Indications for use
The Capnostream™35 is a portable capnograph/pulse oximeter, intended to provide professionally trained health care providers with continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath, respiration rate, arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients. The pulse oximeter is intended for use during both no motion and motion conditions and for patients who are well or poorly perfused. The Capnostream™35 also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for age 22 and up. The device is intended for use in hospitals, hospital-type facilities, during intra-hospital transport, and out-of-hospital Emergency Medical Service applications that include ground and air transport.

Source page: https://510kreport.com/device/K150272
Methodology: https://510kreport.com/methodology