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Respiree Cardio- Respiratory Monitor System

by Respiree Pte, Ltd.

510(k) K250934

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250934↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK250934 Date5 Aug 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
BZQ
Device Class
Class II
Regulation
21 CFR Part 868.2375
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

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

The Respiree Cardio-Respiratory Monitor System is a Class II medical device designed for continuous, non-invasive monitoring of cardio-respiratory parameters. It measures physiological indicators such as breathing frequency, tidal volume, inhalation/exhalation times, respiratory rate, oxygen saturation (SpO₂), and pulse rate in real-time or episodic intervals. The system is intended for use in non-intensive care settings, including hospitals and home environments, to support clinical decision-making and patient management.

This device is supplied as a wearable chest sensor paired with a finger sensor, integrated with software for data acquisition, analysis, and remote monitoring. It is intended for single-use or reusable configurations, depending on clinical protocols, and does not require MRI compatibility. The system is authorized under FDA 510(k) clearance (K250934) and MDR compliance, with regulatory classification under 868.2375. Storage and handling follow standard medical device protocols to ensure accuracy and reliability.

Other devices from Respiree Pte, Ltd.

Questions

AI-generated answers, 18 Sep 2026

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

  • What types of environments is the Respiree Cardio-Respiratory Monitor System designed for, and how does it differ from intensive care settings?

    The Respiree Cardio-Respiratory Monitor System is specifically designed for non-intensive care settings, including hospitals and home environments. Unlike intensive care monitors, it focuses on continuous, non-invasive monitoring of cardio-respiratory parameters like breathing frequency, tidal volume, and oxygen saturation (SpO₂) to support clinical decision-making and patient management in less critical care areas. Its wearable chest and finger sensors enable real-time or episodic monitoring without requiring specialized ICU infrastructure.

  • How is the Respiree Cardio-Respiratory Monitor System supplied, and can the sensors be reused?

    The system is supplied as a wearable chest sensor paired with a finger sensor, integrated with software for data acquisition and remote monitoring. The device is intended for single-use or reusable configurations, depending on clinical protocols. Reusability should be determined by facility-specific policies to ensure hygiene and accuracy, as the system does not specify mandatory single-use requirements in its design.

  • What key physiological parameters does the Respiree Cardio-Respiratory Monitor System measure, and how might this benefit patient monitoring?

    The system measures breathing frequency, tidal volume, inhalation/exhalation times, respiratory rate, oxygen saturation (SpO₂), and pulse rate in real-time or episodic intervals. This comprehensive monitoring helps clinicians assess respiratory effort, detect early signs of respiratory distress, and track vital signs without invasive procedures, making it useful for patients in non-intensive care settings where continuous observation is needed but ICU-level intervention isn’t required.

  • Does the Respiree Cardio-Respiratory Monitor System require any special handling or storage conditions?

    The system follows standard medical device protocols for storage and handling to maintain accuracy and reliability. While specific storage conditions (e.g., temperature, humidity) aren’t detailed in the data, adherence to general medical device guidelines—such as protecting sensors from physical damage and contamination—is recommended. The system is not MRI-compatible, so magnetic fields should be avoided during use or storage.

  • What regulatory pathways has the Respiree Cardio-Respiratory Monitor System undergone, and how does this affect its use?

    The device has been authorized through FDA 510(k) clearance (K250934) and MDR compliance, with a regulatory classification under 868.2375. This means it has been deemed substantially equivalent to a predicate device by the FDA and meets EU medical device regulations. Clinicians and buyers can rely on these pathways to confirm the system’s compliance with safety and performance standards, though local regulatory requirements should always be verified before use.