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Non-Rebreathing T Piece

by Dhd Medical Products Div. Diemolding Corp. 510(k)

Active United States

510(k) K790820

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK790820 Date4 May 1979ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Non-Rebreathing T Piece is a Valve, Non-Rebreathing (per FDA classification), designed to prevent exhaled gases from re-entering the breathing circuit during anesthesia administration. It ensures unidirectional airflow, directing patient exhalation away from the inspiratory limb while maintaining a sealed connection between the patient and ventilatory system.

This device is intended for use in anesthesiology settings, supplied as a single-use component for respiratory circuits. It requires no sterilization beyond manufacturer-provided packaging and is classified as Class II under FDA regulations (Regulation 868.5870). The device is non-magnetic and compatible with standard anesthetic equipment, with no reported MRI restrictions. Sizes or variants are not specified in the regulatory data.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the purpose of the Dhd Non-Rebreathing T Piece Valve?

    The Dhd Non-Rebreathing T Piece Valve is designed to prevent exhaled gases from flowing back into the breathing circuit during anesthesia administration. It ensures one-way airflow, directing patient exhalation away from the inspiratory limb while maintaining a sealed connection between the patient and ventilatory system. This design minimizes gas contamination and maintains the integrity of the anesthetic circuit.

  • How is the Dhd Non-Rebreathing T Piece Valve supplied and prepared for use?

    The device is supplied as a single-use component, meaning it is intended for one-time use only. No additional sterilization is required beyond the manufacturer-provided packaging, which ensures sterility for clinical use. This eliminates the need for reprocessing and reduces the risk of cross-contamination between patients.

  • Is the Dhd Non-Rebreathing T Piece Valve reusable or single-use?

    The Dhd Non-Rebreathing T Piece Valve is explicitly designed for single-use only. This classification aligns with best practices in medical device safety, as single-use devices minimize the risk of infection and ensure consistent performance without degradation from repeated use or sterilization processes.

  • Are there different sizes or models available for the Dhd Non-Rebreathing T Piece Valve?

    The regulatory data does not specify any variations in sizes or models for the Dhd Non-Rebreathing T Piece Valve. It is intended as a standardized component for use in respiratory circuits within anesthesiology settings, ensuring compatibility with common anesthetic equipment without requiring customization.

  • How should the Dhd Non-Rebreathing T Piece Valve be stored?

    The device should be stored in its original, unopened manufacturer-provided packaging to maintain sterility and integrity. Proper storage conditions include keeping it in a clean, dry environment, protected from physical damage, extreme temperatures, and direct sunlight. Follow the manufacturer’s instructions for storage duration and handling to ensure optimal performance and safety.