Fluid Handling Device W/Input Tubing

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

510(k) Number

K771453 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• The Imed Ambulatory Infusion Pump, Administration Sets

  Class II

  FDA 510(k) K953896 Active Cleared 20 Mar 1996

• Macrodot Add-I-Med Admin. Set

  Class II

  FDA 510(k) K823347 Active Cleared 24 Nov 1982

• Imed Gemini 12 Nonvented Y-Type Blood/Solution Adm

  Class II

  FDA 510(k) K894842 Active Cleared 12 Sep 1989

• Imed(R) Gemini(Tm) Pc-1 Volumetric Infusion Pump

  Class II

  FDA 510(k) K880479 Active Cleared 25 Apr 1988

• IV Filterset 5 Micrometer

  Class II

  FDA 510(k) K813445 Active Cleared 5 Jan 1982

• Imed Accuset Cassette

  Class II

  FDA 510(k) K812035 Active Cleared 28 Jul 1981

See all devices from Imed Corp. →

• Is this device designed for single-use or can it be reused in clinical settings?

  This device is supplied as a reusable assembly, meaning it is intended to be cleaned and reused after each patient use. The elastic force-driven mechanism and input tubing are part of a system designed for repeated use in controlled clinical environments where proper maintenance and sterilization protocols are followed.

• What types of fluids can this device administer, and how does it ensure controlled delivery?

  The device is specifically designed for the continuous or intermittent percutaneous infusion of medicated solutions, ensuring precise fluid management through an elastic force-driven mechanism. This system regulates flow via the input tubing, making it suitable for administering prescribed liquids in clinical settings where accurate dosing is critical.

• How is this device classified under FDA regulations, and what does that mean for its use?

  This device falls under FDA product code FPA, classified as a General Hospital use item under the Hospital Orthopedics (HO) advisory committee. It was granted Substantially Equivalent (SESE) status in 1977 via a Traditional 510(k) clearance, meaning it was determined to be as safe and effective as a legally marketed device already on the market at the time. This classification ensures it meets regulatory standards for fluid administration in clinical environments.

• Where is this device manufactured, and what are the key details about its regulatory history?

  The device is manufactured by Imed Corp. with its headquarters at 803 N. Front St., Suite 3, Mchenry, IL 60050, USA. It received FDA 510(k) clearance (K771453) in 1977, with no third-party review involved. The clearance was based on a Substantially Equivalent determination, confirming its compliance with existing standards for fluid handling in hospital settings at the time of submission.