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Resuscitation Bag Controller (RBC)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K882278

by Physician Engineered Products, Inc.

Identifiers

510(k) Number
K882278 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 Resuscitation Bag Controller (RBC) is a manual emergency resuscitator ventilator designed to control self-refilling resuscitation enclosures. The apparatus features a pair of arms pivotable between open and closed positions, with an inside strap fixed to both arms and an outside strap fixed to one arm.

The outer strap is releasably coupled at various locations along the opposite arm to selectively limit the amount of resuscitation provided. This device is regulated under FDA 510(k) clearance K882278 as a class 2 medical device.

Frequently asked questions

What is the primary function of the Resuscitation Bag Controller?

The Resuscitation Bag Controller is a manual emergency resuscitator ventilator designed to control self-refilling resuscitation enclosures. It uses a system of pivotable arms and straps to selectively limit the amount of resuscitation provided to a patient.

How does the device limit the resuscitation volume?

The apparatus features an outer strap that is releasably coupled at various locations along the opposite arm. By adjusting the coupling point of this strap, the user can selectively limit the compression of the resuscitation bag, thereby controlling the amount of resuscitation provided.

What is the regulatory status of this device?

The Resuscitation Bag Controller is regulated as a class 2 medical device under FDA 510(k) clearance K882278. It falls under the product code BTM and is categorized within the anesthesiology medical specialty.

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: Resuscitation Bag Controller (Rbc) - Beudamed, PHYSICIAN ENGINEERED PRODUCTS, INC. - fda.report, Resuscitation bag control apparatus - Physician Engineered Products, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Physician Engineered Products, Inc.

Sources (1)

  • FDA 510(k) K882278 24 fields · synced Sep 25, 2026