# K253030: Capnostream™35 Portable Respiratory Monitor (PM35MN)

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: May 1, 2026 after 224 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K962603 (1997). 73 ancestors in all.
No later device cites it as a predicate yet.
1 of 74 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200594: Capnostream 35 Portable Respiratory Monitor, Oridion Medical 1987, Ltd. (2020) Summary page 7.

## Indications for use
The Capnostream ™ 35 monitor is a portable capnograph and pulse oximetry monitor indicated for non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath (EtCO2), respiration rate (RR), arterial oxygen saturation (SpO2), and pulse rate (PR) in patient populations, including adults, pediatrics, and neonates. The Capnostream ™ 35 monitor is indicated for use by professionally trained health care providers. The Capnostream ™ 35 monitor is intended for use in hospitals, hospital-type facilities, intra-hospital transport, mobile emergency medical applications including both ground and air transport, unless otherwise noted. Transport environments include intra-hospital transport and both ground and air emergency transport: road ambulances and rotary-wing aircraft. The Capnostream ™ 35 monitor with Microstream™ capnography and accessories is indicated for continuous non-invasive monitoring of capnography-derived respiratory rate, integrated pulmonary index (IP1), 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 adult patients only. The Capnostream™ 35 monitor with Nellcor™ pulse oximeter and accessories are indicated for providing spot-check and/or continuous non-invasive monitoring of arterial oxygen saturation (SpO2), pulse rate (PR), pleth-derived respiratory rate, Saturation Pattern Detection (SPD), heart rate variability (HRV), and perfusion index (PI). It is intended for use with patients who are well- or poorly perfused, during both no-motion and motion conditions. The device is intended to maintain accuracy in monitoring conditions in which patient and/or pulse oximetry sensor characteristics may affect measurements, by leveraging patient-specific and sensor-specific information to aid in arterial oxygen saturation calculation. The Saturation Pattern Detection™ Alert (SPD) parameter is intended to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs for continuous monitoring of adults in hospital, hospital-type facilities, and during intra-hospital transport only. The Respiration Rate (RR) parameter, when used in conjunction with a NellcorTM Respiration Rate sensor, is intended to be used for spot-check or continuous monitoring of respiration rate in adults in hospital, hospital-type facilities, and during and intra-hospital transport only. The Heart Rate Variability (HRV) is intended for continuous monitoring of the variability of a patient’s pulse rate. The Heart Rate Variability is intended to analyze the pulse rate provided by the oximeter and provide visualization of trends in the pulse rate and HRV values. The perfusion index is intended for spot-check or continuous monitoring of peripheral perfusion at the pulse oximetry sensor site and provides the ratio of the pulsatile blood to non-pulsatile or static blood in peripheral tissue.

Source page: https://510kreport.com/device/K253030
Methodology: https://510kreport.com/methodology