Skip to content

Cpr Bio-Barrier Facesheild

by O-Two Systems Intl., Inc. 510(k)

Active United States

510(k) K960995

Overview

The CPR Bio-Barrier Face Shield is a protective barrier device designed to prevent fluid transfer during cardiopulmonary resuscitation (CPR) training. It functions as a physical barrier to block bacteria and viruses, ensuring a sterile environment during practice sessions. The device is classified as a valve, non-rebreathing type, and is intended for use in anesthesiology settings.

This single-use device is supplied sterile and is intended for use in training scenarios to minimize contamination risks. It is classified as a Class 2 medical device under FDA regulation 868.5870 and has received FDA 510(k) clearance (K960995) through the Traditional pathway. The face shield is designed to be durable and clear, facilitating visibility during CPR training while maintaining filtration integrity.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK960995 Date7 Jan 1997ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CBP
Device Class
Class II
Regulation
21 CFR Part 868.5870
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from O-Two Systems Intl., Inc.

See all devices from O-Two Systems Intl., Inc. →

Questions

  • What is the CPR Bio-Barrier Face Shield used for?

    The CPR Bio-Barrier Face Shield is designed as a protective barrier device specifically for use during cardiopulmonary resuscitation (CPR) training. It acts as a physical barrier to prevent fluid transfer, reducing contamination risks and maintaining a sterile environment during practice sessions. This is particularly useful in anesthesiology settings where minimizing exposure to pathogens is critical.

  • Is the CPR Bio-Barrier Face Shield sterile and single-use?

    Yes, the CPR Bio-Barrier Face Shield is supplied sterile and is intended for single-use only. This ensures that each training session begins with a clean, uncontaminated barrier, reducing the risk of cross-transmission of bacteria or viruses between users and sessions.

  • How is the CPR Bio-Barrier Face Shield classified and regulated?

    The CPR Bio-Barrier Face Shield is classified as a Class 2 medical device under FDA regulation 868.5870 and has received FDA 510(k) clearance through the Traditional pathway. It is also categorized as a valve, non-rebreathing type, which aligns with its function as a protective barrier during CPR training.

  • What are the key features of the CPR Bio-Barrier Face Shield?

    The CPR Bio-Barrier Face Shield is designed to be durable and clear, allowing for optimal visibility during CPR training while maintaining filtration integrity. Its transparency ensures that trainers can observe hand placement and technique accurately, and its durability supports repeated use in training scenarios without compromising its protective properties.

  • How should the CPR Bio-Barrier Face Shield be stored?

    While specific storage instructions are not detailed in the provided data, single-use sterile devices like the CPR Bio-Barrier Face Shield should generally be stored in a clean, dry environment, protected from direct sunlight and extreme temperatures. Ensure the packaging remains intact until immediate use to maintain sterility.