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Mercury CPR Complete Personal Resuscitator Bag with Expandable Reservoir

FDA 510(k)

Class II (US FDA 510(k))

510(k) K954866

by Mercury Medical

Identifiers

510(k) Number
K954866 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 Mercury CPR Complete Personal Resuscitator Bag with Expandable Reservoir is a manual resuscitator designed for emergency ventilation. Classified as a ventilator under OpenFDA’s nomenclature, it provides positive pressure ventilation without requiring a compressed gas source, making it suitable for cardiopulmonary resuscitation (CPR) and other emergency respiratory support scenarios.

This device is supplied as a single-use, non-sterile disposable and is intended for use in pre-hospital and clinical settings. It features an expandable reservoir for oxygen delivery and is regulated under FDA 510(k) clearance (K954866) with a classification of Class II. The device is not MRI-safe and must be stored in a clean, dry environment as per manufacturer guidelines.

Frequently asked questions

What is the primary use case for the Mercury CPR Complete Personal Resuscitator Bag with Expandable Reservoir, and where can it be deployed?

The Mercury CPR device is designed for emergency ventilation, specifically for scenarios requiring positive pressure ventilation without a compressed gas source. This makes it ideal for cardiopulmonary resuscitation (CPR) and other urgent respiratory support situations. It is approved for use in both pre-hospital settings (e.g., ambulances, first responder environments) and clinical settings (e.g., hospitals, emergency rooms). The expandable reservoir enhances oxygen delivery, ensuring consistent airflow during resuscitation efforts.

Is the Mercury CPR device single-use or reusable, and what does that mean for sterility and handling?

The Mercury CPR device is single-use and non-sterile, meaning it is intended for one-time use only per patient. This design eliminates the need for reprocessing but requires clinicians to follow aseptic techniques when handling it, such as using sterile gloves and avoiding contamination before use. After use, the device should be discarded according to local medical waste protocols.

How should the Mercury CPR device be stored, and are there any environmental restrictions?

The device must be stored in a clean, dry environment to maintain its integrity. While it is not sterile, keeping it free from moisture, dust, or direct sunlight ensures it remains functional for its intended single-use scenario. The manufacturer does not specify temperature ranges, but standard room temperature storage (typically 15–30°C/59–86°F) is recommended. Avoid storing it in areas prone to extreme humidity or contamination.

What regulatory pathway does the Mercury CPR device follow, and how does that affect its availability?

The Mercury CPR device received FDA 510(k) clearance (K954866), confirming it is classified as substantially equivalent to a predicate device. This means it has undergone FDA review for safety and effectiveness as a Class II ventilator under the OpenFDA nomenclature. While the clearance does not imply universal availability, it confirms the device meets U.S. regulatory standards for emergency ventilation devices. Availability may vary by region or distributor, so purchasing through authorized channels is advised.

Can the Mercury CPR device be used in an MRI environment, and what precautions should be taken during transport?

The Mercury CPR device is not MRI-safe, meaning it should never be brought into an MRI scanning area. If transporting the device near MRI facilities, ensure it is removed from the vicinity of the magnet to avoid potential interference or damage. Additionally, since it is non-sterile and single-use, avoid exposing it to contaminants during transport, such as placing it in a sealed, protected case.

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: CPR-2 Thermoplastic Resuscitators (Disposable) - Mercury Medical, CPR-2+® Modern Adult Resuscitator - Mercury Medical, Mercury CPR, CPR-2 and CPR-2+ Resuscitators - Life-Assist

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mercury Medical

Sources (1)

  • FDA 510(k) K954866 24 fields · synced Sep 19, 2026