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Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K181524

by Vyaire Medical, Inc.

Identifiers

510(k) Number
K181524 FDA 510(k)
FDA Product Code
BZC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.1880 FDA 510(k)
Regulation Number
868.1880 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Vyntus ONE is a pulmonary function testing device that can be configured with various accessories including carts and ECG equipment for cardiopulmonary exercise testing. It is designed for use in medical settings to assess pulmonary function and can be combined with exercise equipment such as bikes and treadmills.

The device is supplied in multiple configurations with or without adjustable carts and with or without PFT only options. It is regulated under FDA 510K clearance with product code BZC and is intended for use in anesthesiology settings. The device is manufactured by Vyaire Medical, Inc. and has a K-number of K181524.

Frequently asked questions

What is the Vyntus ONE device used for?

The Vyntus ONE is a pulmonary function testing device designed for medical settings to assess pulmonary function. It can be configured with various accessories including carts and ECG equipment for cardiopulmonary exercise testing, and can be combined with exercise equipment such as bikes and treadmills.

What configurations are available for the Vyntus ONE?

The Vyntus ONE is supplied in multiple configurations: with or without adjustable carts, and with or without PFT only options. This allows flexibility in setup depending on the specific testing requirements of the medical facility.

What is the regulatory status of the Vyntus ONE?

The Vyntus ONE is regulated under FDA 510K clearance with product code BZC and has a K-number of K181524. It is intended for use in anesthesiology settings and was granted clearance on November 30, 2018.

Who manufactures the Vyntus ONE device?

The Vyntus ONE is manufactured by Vyaire Medical, Inc., a company that specializes in respiratory care products. The device is part of their portfolio of pulmonary function testing equipment designed for clinical use.

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: Vyntus ONE - Linde, Vyntus™ BODY Plethysmograph – GHA – German Health Alliance, Vyntus - Vyaire

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Vyaire Medical, Inc.

Sources (1)

  • FDA 510(k) K181524 24 fields · synced Oct 6, 2026