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ExSpiron 1Xi

FDA 510(k)

Class II (US FDA 510(k))

510(k) K162131

by Respiratory Motion, Inc.

Identifiers

510(k) Number
K162131 FDA 510(k)
FDA Product Code
BZK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.1850 FDA 510(k)
Regulation Number
868.1850 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ExSpiron 1Xi is an impedance-based respiratory volume monitoring device that provides continuous real-time measurements of minute ventilation, tidal volumes, and breathing frequency. It is designed for point-of-care respiratory assessment to help clinicians initiate timely interventions. The device uses an electrode PadSet placed on the thorax to monitor respiratory parameters.

The ExSpiron 1Xi is supplied as a monitoring device that can be connected to a Nurse Call Accessory (Respiratory Motion P/N RMI-51155) for audible alarm communication. It is authorized under FDA 510K (K162131) and classified as a Spirometer, Monitoring (W/Wo Alarm) with device class 2. The device is intended for use in various clinical settings, though specific regulatory status beyond FDA clearance is not stated in the provided data.

Frequently asked questions

What is the ExSpiron 1Xi used for?

The ExSpiron 1Xi is an impedance-based respiratory volume monitoring device designed for point-of-care respiratory assessment. It provides continuous real-time measurements of minute ventilation, tidal volumes, and breathing frequency to help clinicians initiate timely interventions.

How is the ExSpiron 1Xi supplied?

The ExSpiron 1Xi is supplied as a monitoring device that can be connected to a Nurse Call Accessory (Respiratory Motion P/N RMI-51155) for audible alarm communication. It includes an electrode PadSet placed on the thorax to monitor respiratory parameters.

What is the regulatory status of the ExSpiron 1Xi?

The ExSpiron 1Xi is authorized under FDA 510K (K162131) and classified as a Spirometer, Monitoring (W/Wo Alarm) with device class 2. It is intended for use in various clinical settings, though specific regulatory status beyond FDA clearance is not stated in the provided data.

Is the ExSpiron 1Xi reusable or single-use?

The device data does not specify whether the ExSpiron 1Xi is reusable or single-use. The electrode PadSet is mentioned as being placed on the thorax, but no information is provided about its disposability or the reusability of the main device unit.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ExSpiron | CareVie Medical, ExSpiron | Senzime, Rev E ExSpiron 1xi Pediatrics Electronic User Manual, ExSpiron 1Xi by Respiratory Motion Inc. | FDA 510 (k) Summary

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Respiratory Motion, Inc.

Sources (1)

  • FDA 510(k) K162131 24 fields · synced Sep 25, 2026