Skip to content

CAPNOSTREAM20 With Integrated Pulmonary Index

by Oridion Capnography, Inc.

510(k) K082268

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

9 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK082268 Date6 Feb 2009ClearedStatusActive

Recalls

9 recalls · FDA

  • 9 recalls, same reason

    • Terminated Z-0034-2019 FDA Class II initiated 31 Jul 2018
    • Terminated Z-0035-2019 FDA Class II initiated 31 Jul 2018
    • Terminated Z-0030-2019 FDA Class II initiated 31 Jul 2018
    • Terminated Z-0028-2019 FDA Class II initiated 31 Jul 2018
    • Terminated Z-0024-2019 FDA Class II initiated 31 Jul 2018 on shared 510(k) K082268
    • Terminated Z-0020-2019 FDA Class II initiated 31 Jul 2018
    • Terminated Z-0033-2019 FDA Class II initiated 31 Jul 2018
    • Terminated Z-0029-2019 FDA Class II initiated 31 Jul 2018
    • Terminated Z-0031-2019 FDA Class II initiated 31 Jul 2018

    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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DQA
Device Class
Class II
Regulation
21 CFR Part 870.2700
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Capnostream20 With Integrated Pulmonary Index is a bedside patient monitor designed for continuous capnography and pulse oximetry. It measures end-tidal carbon dioxide (EtCO₂), respiration rate, oxygen saturation (SpO₂), and pulse rate in real time. The device also calculates an Integrated Pulmonary Index (IPI), a numerical score (1–10) reflecting ventilatory status. This monitor is classified as a Capnograph and Pulse Oximeter under regulatory nomenclature, enabling non-invasive assessment of respiratory and oxygenation parameters.

Used primarily in critical care, anesthesia, and neonatal units, the Capnostream20 is intended for single-patient use and is not sterile. It operates in clinical settings where real-time respiratory monitoring is required, with no MRI compatibility specified. The device is supplied as a reusable monitor with disposable sensor attachments. Its regulatory clearance under FDA 510K (K082268) confirms compliance with U.S. medical device standards for bedside monitoring applications.

Other devices from Oridion Capnography, Inc.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical applications does the Capnostream20 With Integrated Pulmonary Index support?

    The Capnostream20 is designed for continuous monitoring in critical care, anesthesia, and neonatal units. It provides real-time data on end-tidal carbon dioxide (EtCO₂), respiration rate, oxygen saturation (SpO₂), and pulse rate. The device’s Integrated Pulmonary Index (IPI), a numerical score from 1–10, helps assess ventilatory status, making it particularly useful in settings where non-invasive respiratory and oxygenation parameters are critical.

  • Is the Capnostream20 With Integrated Pulmonary Index sterile or single-use?

    The Capnostream20 is a reusable monitor intended for single-patient use. While the device itself is not sterile, it is supplied with disposable sensor attachments, ensuring hygiene and compliance with clinical protocols for patient monitoring.

  • How is the Capnostream20 With Integrated Pulmonary Index supplied?

    The device comes as a reusable monitor with disposable sensor attachments. This design allows for easy replacement of sensors between patients, reducing cross-contamination risks while maintaining the functionality of the core monitoring unit.

  • What regulatory clearance does the Capnostream20 With Integrated Pulmonary Index hold?

    The Capnostream20 With Integrated Pulmonary Index holds FDA 510K clearance under the reference number K082268. This clearance confirms its compliance with U.S. medical device standards for bedside monitoring applications, specifically as a capnograph and pulse oximeter.

  • Does the Capnostream20 With Integrated Pulmonary Index have any MRI compatibility?

    The device’s specifications do not mention MRI compatibility, meaning it should not be used in MRI environments. Clinicians should verify local protocols and ensure the device is placed outside MRI zones to avoid interference or safety risks.