Impact Model E-12

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

510(k) Number

K820330 ↗

FDA Product Code

JCX

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 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

• Impact Model 601

  Class II

  FDA 510(k) K841537 Active Cleared 31 May 1984

See all devices from Impact Instrumentation, Inc. →

• What is the Impact Model E-12 used for in clinical settings?

  The Impact Model E-12 is designed as a portable, AC-powered suction apparatus for controlled aspiration of fluids, debris, or secretions from patients. It is specifically intended for general and plastic surgery applications, aiding in wound care, surgical procedures, and postoperative recovery by maintaining patient hygiene and procedural conditions.

• Is the Impact Model E-12 a single-use or reusable device?

  The Impact Model E-12 is a reusable device. It requires proper maintenance and sterilization between uses to ensure safety and functionality, as outlined in the manufacturer’s guidelines.

• What type of power source does the Impact Model E-12 use?

  The Impact Model E-12 operates on AC power, making it suitable for use in hospital or surgical environments where such power is readily available.

• How is the device classified under FDA regulations?

  The Impact Model E-12 is classified as a Class II medical device under FDA regulation 878.4780. It holds an FDA 510(k) clearance (K820330) with a decision of Substantially Equivalent to a predicate device, issued in 1982.

• What storage and handling requirements does the Impact Model E-12 have?

  The Impact Model E-12 must be stored and handled according to the manufacturer’s guidelines to ensure its functionality and safety. Proper maintenance and sterilization procedures are critical, especially since it is a reusable device.