Skip to content

Plume Master

by Sorex Medical 510(k)

Active United States

510(k) K913036

Overview

The Plume Master is an Apparatus, Exhaust, Surgical designed for surgical smoke evacuation. It is intended to remove airborne contaminants, including surgical smoke and fumes, generated during procedures to maintain a safer operating environment for patients and staff.

This device is supplied as a reusable system and is classified under FDA regulation 878.5070 with a 510(k) clearance (K913036). It is intended for use in surgical settings, particularly within General and Plastic Surgery, and operates as a Class II medical device. No specific sterility or MRI safety information is provided in the data.

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

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK913036 Date6 Sep 1991ClearedStatusActive

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
FYD
Device Class
Class II
Regulation
21 CFR Part 878.5070
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Other devices from Sorex Medical

See all devices from Sorex Medical →

Questions

  • What is the Plume Master used for?

    The Plume Master is an Apparatus, Exhaust, Surgical designed specifically to remove airborne contaminants, including surgical smoke and fumes, generated during surgical procedures. This helps maintain a safer operating environment for both patients and healthcare staff by reducing exposure to potentially harmful particles.

  • Is the Plume Master reusable or single-use?

    The Plume Master is supplied as a reusable system. It is intended for repeated use in surgical settings, which helps reduce waste and costs associated with single-use devices. However, proper cleaning and maintenance are essential to ensure its continued effectiveness and safety.

  • What surgical specialties is the Plume Master intended for?

    The Plume Master is primarily intended for use in surgical settings within General and Plastic Surgery. Its design focuses on mitigating airborne contaminants that arise during these types of procedures, ensuring a cleaner and safer workspace.

  • How is the Plume Master supplied, and what should be considered for storage?

    The Plume Master is supplied as a reusable system, meaning it is designed for multiple uses after proper cleaning and maintenance. Since it is reusable, storage should be done in a clean, dry environment to prevent contamination or damage. Follow manufacturer guidelines for cleaning protocols and storage conditions to ensure optimal performance and longevity.

  • What regulatory pathway does the Plume Master follow?

    The Plume Master is classified under FDA regulation 878.5070 and has received a 510(k) clearance (K913036). This classification and clearance indicate that it has been deemed substantially equivalent to a legally marketed device and meets the necessary safety and performance standards for its intended use as a surgical smoke evacuation apparatus.