Electric Vacum Pump

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K941096 ↗

FDA Product Code

BTA

Device Class

Class II

Regulation

21 CFR Part 878.4780

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Impact, Models 306/307

  Class II

  FDA 510(k) K820338 Active Cleared 2 Mar 1982

• Impact Model E-12

  Class II

  FDA 510(k) K820330 Active Cleared 23 Feb 1982

• Impact Model 308

  Class II

  FDA 510(k) K841538 Active Cleared 11 Jun 1984

• Impact Model 753

  Class II

  FDA 510(k) K931473 Active Cleared 30 Dec 1994

• Impact 901 Series Port-a-Wall

  Class I

  FDA 510(k) K850671 Active Cleared 11 Mar 1985

• Impact, Universal Single-Limb, Ventilator Circuit, Model 820-0099-00

  Class II

  FDA 510(k) K022062 Active Cleared 6 May 2003

See all devices from Impact Instrumentation, Inc. →

• What is the Electric Vacuum Pump used for?

  The Electric Vacuum Pump is indicated for general and plastic surgery applications as a portable aspiration device used for manual or powered suction, based on its classification under FDA regulation number 878.4780.

• Is the Electric Vacuum Pump sterile or non-sterile when supplied?

  The device is supplied non-sterile, as stated in the specifications, and is intended for reuse, meaning it must be cleaned and sterilized by the user before each use according to their facility's protocols.

• Can the Electric Vacuum Pump be reused, and what does that mean for its use?

  The Electric Vacuum Pump is intended for reuse, which means it is designed to be used multiple times after appropriate cleaning and sterilization procedures, rather than being discarded after a single use.

• What powers the Electric Vacuum Pump, and how does it operate?

  The device operates using electrical power, making it a powered suction system that does not rely on manual effort alone, allowing for consistent aspiration during procedures.

• Are there any specific models or references that distinguish this Electric Vacuum Pump from others?

  This device is identified by the name 'ELECTRIC VACUM PUMP' and the manufacturer Impact Instrumentation, Inc., with the FDA 510(k) number K941096, which distinguishes it as a specific submission under regulation 878.4780.