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NEOVO2R Ventilatory

FDA 510(k)

Class II (US FDA 510(k))

510(k) K885243

by Neomed

Identifiers

510(k) Number
K885243 FDA 510(k)
FDA Product Code
BTM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5915 FDA 510(k)
Regulation Number
868.5915 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Neovo2r Ventilatory is a ventilator, emergency, manual (resuscitator) designed for mechanical ventilation support in critical care settings. It provides controlled or assisted ventilation to patients requiring respiratory assistance, including those undergoing anesthesia or resuscitation. The device is classified as a Class II medical device under FDA regulations, intended for use in controlled breathing environments where manual operation is required.

This ventilator is supplied as a reusable medical device and is regulated under FDA regulation 868.5915. It is intended for use in clinical settings such as operating rooms, emergency departments, and intensive care units, where precise control of ventilation parameters is necessary. The Neovo2r Ventilatory received FDA 510(k) clearance (K885243) in 1989, demonstrating its compliance with regulatory standards for safety and performance in manual ventilation applications.

Frequently asked questions

Is the Neovo2r Ventilatory designed for single-use or can it be reused in clinical settings?

The Neovo2r Ventilatory is explicitly described as a reusable medical device. It is intended for use in controlled environments like operating rooms, emergency departments, and intensive care units, where repeated sterilization and maintenance are feasible. Reusability aligns with its classification as a Class II device under FDA regulations, which often includes durable equipment requiring reprocessing.

What clinical environments is the Neovo2r Ventilatory intended for, and why?

The Neovo2r Ventilatory is designed for critical care settings where precise manual ventilation is required, including operating rooms, emergency departments, and intensive care units. This is because it provides controlled or assisted ventilation for patients undergoing anesthesia or resuscitation, where reliability and adjustability are critical. The device’s manual operation also makes it suitable for scenarios where electrical power may be unreliable or unavailable.

How is the Neovo2r Ventilatory regulated by the FDA, and what does that mean for its use?

The Neovo2r Ventilatory received FDA 510(k) clearance (K885243) in 1989, demonstrating it meets regulatory standards for safety and performance as a manual resuscitator. This clearance indicates it is substantially equivalent to a legally marketed device and is classified under FDA regulation 868.5915, which governs emergency manual ventilators. Clinically, this means it has undergone FDA review for its intended use in controlled breathing environments, ensuring compliance with U.S. medical device regulations.

Does the Neovo2r Ventilatory come with multiple models or sizes, and if so, how does that affect its versatility?

While the provided data lists multiple registration numbers (e.g., 3013557562, 3005747797), these are administrative identifiers (likely for inventory or lot tracking) and do not explicitly describe distinct models or sizes. However, the device’s classification as a manual resuscitator suggests it may accommodate various patient interfaces (e.g., masks, endotracheal tubes) to adapt to different clinical needs. For precise sizing or model-specific details, consulting the manufacturer’s technical documentation or contacting Neomed directly would be necessary.

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: NEOVO2R VENTILATORY (K885243) — FDA 510 (k) | Innolitics, NEOVO2R VENTILATORY 510(k) K885243 - FDA.report, Neomed FDA Filings - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Neomed

Sources (1)

  • FDA 510(k) K885243 24 fields · synced Sep 20, 2026