Cobe Centrysystem 145E, 160E, 175E, 190E Dialyzers

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K864831 ↗

FDA Product Code

FJI

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Flowmeter, Optiflo Gas

  Class II

  FDA 510(k) K790546 Active Cleared 11 May 1979

• Cobe Ppd 1.9

  Class II

  FDA 510(k) K812336 Active Cleared 31 Aug 1981

• Cobe Spectra Blood Component Separator Therapeutic

  Unclassified

  FDA 510(k) K900105 Active Cleared 22 Mar 1991

• Cobe Emergency Power Source 43610-000

  Class II

  FDA 510(k) K842138 Active Cleared 3 Aug 1984

• Centry 2 Ultrafiltration Control Kit, #018762-002

  Class II

  FDA 510(k) K881062 Active Cleared 21 Apr 1988

• Cobe Rx Meter

  Class II

  FDA 510(k) K830629 Active Cleared 6 Apr 1983

See all devices from Cobe Laboratories, Inc. →

• What are the Cobe Centrysystem 145E-190E Dialyzers used for?

  These dialyzers are designed specifically for hemodialysis, a renal replacement therapy that removes waste products and excess fluids from the blood. The semipermeable hollow fiber membranes facilitate the exchange of solutes and water between the patient’s blood and the dialysate solution, ensuring efficient filtration during treatment.

• Are these dialyzers intended for single-use or reuse?

  The Cobe Centrysystem 145E-190E Dialyzers are strictly for single-use only. They are supplied sterile and packaged individually, eliminating the need for reprocessing. This ensures patient safety and maintains the integrity of the device’s filtration performance.

• How are the different models (145E, 160E, 175E, 190E) distinguished?

  Each model corresponds to specific membrane surface areas and filtration capacities, tailored to meet varying clinical needs. The numerical differences indicate differences in design parameters, such as membrane size and efficiency, allowing clinicians to select the appropriate dialyzer based on patient requirements.

• Do these dialyzers require any special handling or storage?

  Since they are supplied sterile and intended for single-use, proper storage involves maintaining the sealed packaging until use. Exposure to moisture, extreme temperatures, or contamination should be avoided, as these factors could compromise sterility and performance. Always follow manufacturer guidelines for optimal storage conditions.

• What regulatory pathway does this device follow?

  The Cobe Centrysystem 145E-190E Dialyzers were cleared through the FDA’s 510(k) process, specifically under the Traditional clearance type. They fall under product code FJI and are classified as Class II medical devices, subject to special controls. This pathway ensures compliance with FDA regulations for hemodialysis devices.