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BAG Manual Resuscitator and Accessories

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K251631

by Laerdal Medical AS

Identifiers

510(k) Number
K251631 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 BAG Manual Resuscitator is a manual emergency ventilator designed for use in resuscitation and anesthesia procedures. It delivers positive pressure ventilation to patients requiring temporary respiratory support, such as those in cardiac arrest or undergoing surgical anesthesia.

Supplied as a reusable device, it is intended for use in clinical settings such as operating rooms, emergency departments, and intensive care units. The BAG Manual Resuscitator is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and MDD authorization. Accessories are provided for compatibility with various patient interfaces and ventilation needs.

Frequently asked questions

Is the BAG Manual Resuscitator designed for single-use or reusable applications in clinical settings?

The BAG Manual Resuscitator is explicitly described as a reusable device, intended for use in clinical environments like operating rooms, emergency departments, and intensive care units. This design allows for repeated use after proper cleaning and maintenance, making it suitable for high-volume resuscitation and anesthesia procedures.

What types of patient interfaces and ventilation needs does the BAG Manual Resuscitator support through its accessories?

The device includes accessories to ensure compatibility with various patient interfaces and ventilation requirements. While the exact accessories aren’t detailed, the mention of accessories implies flexibility for different mask sizes, pediatric/adult interfaces, or specialized ventilation scenarios (e.g., high-flow or low-resistance systems) commonly encountered in resuscitation and anesthesia.

How is the BAG Manual Resuscitator regulated, and what does its classification mean for purchasing decisions?

The BAG Manual Resuscitator is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance, indicating it is deemed *substantially equivalent* to a predicate device. It also holds MDD authorization, suggesting compliance with European medical device directives. For buyers, this classification means it undergoes rigorous review for safety and performance, ensuring reliability in emergency and anesthesia settings.

Are there specific models or sizes available for the BAG Manual Resuscitator, and how might they differ?

The provided data doesn’t specify exact models or sizes, but the device is listed with multiple FEI numbers (e.g., 3013557562, 3006061749), which often correlate to variations like pediatric vs. adult sizes, different flow rates, or accessory kits. Clinicians should confirm with Laerdal Medical AS for details on available configurations to match patient needs, as these variations are critical for effective ventilation.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Laerdal Medical AS

Sources (2)

  • FDA 510(k) K251631 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026