Ideal: System With Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator

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

510(k) Number

K030154 ↗

FDA Product Code

KFM

Device Class

Class II

Regulation

21 CFR Part 870.4360

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Dideco Electa Autotransfusion Apparatus

  Class II

  FDA 510(k) K020647 Active Cleared 5 Sep 2002

• Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter and Hardhshell Venous/Cardiotomy

  Class II

  FDA 510(k) K022450 Active Cleared 22 Oct 2002

• Dhf 0.2 Hemoconcentrator: Dideco Newborn-Infant Hemoncentration; Dhr 0.6 Hemoconcentrator: Dideco Pediatric/Small Adult

  Class II

  FDA 510(k) K021732 Active Cleared 4 Nov 2002

• Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator

  Class II

  FDA 510(k) K032040 Active Cleared 9 Jul 2003

• D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 Ph.i.s.i.o. Adult Hollow Fiber Oxygenator with Coating

  Class II

  FDA 510(k) K033323 Active Cleared 13 Jan 2004

• D902 Ph.i.s.i.o Oxygenator; D920 Ph.i.s.i.o Reservoir; Dideco D736 Ph.i.s.i.o Filter

  Class II

  FDA 510(k) K013915 Active Cleared 27 Dec 2001

See all devices from Dideco S.P.A. →

• What is the IDEAL system intended for?

  The IDEAL system is an extracorporeal hemodynamic and gas exchange support system that integrates a microporous hollow fiber membrane oxygenator with a heat exchanger and arterial filter, featuring a centrifugal blood pump and venous air removal device for use in adult surgical procedures requiring cardiopulmonary bypass.

• How is the IDEAL system supplied and is it reusable?

  The IDEAL system is supplied as a sterile, single-use device for extracorporeal perfusion during cardiovascular surgery, meaning it is intended for one-time use only and must not be reprocessed or reused.

• What regulatory pathway was used for the IDEAL system and what is its classification?

  The IDEAL system received FDA 510(k) clearance under product code KFM and is classified as a Class II blood pump for cardiopulmonary bypass, non-roller type, based on its substantial equivalence to a predicate device.