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CPROTECTOR 2000

by Certified Safety Mfg., Inc. 510(k)

Active United States

510(k) K960587

Overview

The CPROTECTOR 2000 is a non-rebreathing valve designed as a physical barrier for mouth-to-mouth resuscitation. It prevents direct contact between the rescuer’s mouth and the patient’s airway, reducing the risk of exposure to potentially contaminated secretions during resuscitation efforts.

This single-use device is intended for use in emergency medical settings, such as pre-hospital care and clinical resuscitation. Supplied sterile and packaged individually, it adheres to FDA 510(k) clearance (K960587) under the classification of a Class II medical device (regulation number 868.5870). It is not MRI-compatible and must be discarded after a single use to maintain sterility and safety standards.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK960587 Date21 Jul 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

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Questions

  • What is the primary purpose of the CPROTECTOR 2000 in emergency medical scenarios?

    The CPROTECTOR 2000 acts as a non-rebreathing valve designed specifically to create a physical barrier during mouth-to-mouth resuscitation. Its main purpose is to prevent direct contact between the rescuer’s mouth and the patient’s airway, thereby reducing the risk of exposure to potentially contaminated secretions during resuscitation efforts in emergency settings like pre-hospital care or clinical resuscitation.

  • Is the CPROTECTOR 2000 reusable, or is it intended for single-use only?

    The CPROTECTOR 2000 is explicitly designed for single-use only. After use, it must be discarded to maintain sterility and safety standards, as outlined in its regulatory documentation.

  • How is the CPROTECTOR 2000 supplied, and what does this mean for its handling?

    The CPROTECTOR 2000 is supplied sterile and packaged individually. This means each unit is pre-sterilized and sealed to ensure it remains uncontaminated until use, requiring no additional sterilization procedures before application.

  • What regulatory pathway was followed for the CPROTECTOR 2000, and what does this imply for its use?

    The CPROTECTOR 2000 follows the FDA 510(k) clearance pathway, classified as a Class II medical device under regulation number 868.5870. This implies it has been determined to be substantially equivalent to a legally marketed device and is intended for use in emergency medical settings, adhering to FDA standards for safety and effectiveness.

  • Can the CPROTECTOR 2000 be used in an MRI environment, or are there any compatibility concerns?

    The CPROTECTOR 2000 is explicitly stated as not MRI-compatible. This means it should not be used in or near MRI machines, as its materials or structure may interfere with MRI functionality or pose safety risks.