Cobe Centrysystem Hollow Fiber Dialyzers

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

510(k) Number

K881811 ↗

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 is the primary purpose of the COBE CENTRYSYSTEM Hollow Fiber Dialyzers in clinical settings?

  The COBE CENTRYSYSTEM Hollow Fiber Dialyzers are designed for renal replacement therapy, specifically hemodialysis. They function by filtering waste products and excess fluids from the blood through semipermeable hollow fiber tubes, allowing solute and fluid exchange between the blood and dialysate during treatment.

• How is this device classified and what regulatory pathway was followed for its approval?

  This device is classified as a Class II medical device under product code FJI and received FDA 510(k) clearance (K881811) through a traditional review process. The clearance was granted on September 15, 1988, based on a determination of substantial equivalence to a predicate device, as reviewed by the Gastroenterology-Urology (GU) Advisory Committee.

• Are there specific storage instructions or handling requirements mentioned for the COBE CENTRYSYSTEM Hollow Fiber Dialyzers?

  The provided data does not specify storage instructions or handling requirements for the COBE CENTRYSYSTEM Hollow Fiber Dialyzers. Since it is not explicitly labeled as sterile, single-use, or reusable, users should refer to manufacturer guidelines or additional documentation for proper storage and handling protocols.

• What medical specialties are associated with the use of this device according to regulatory records?

  The regulatory records indicate that the COBE CENTRYSYSTEM Hollow Fiber Dialyzers are associated with the medical specialties of Gastroenterology and Urology, as noted in the advisory committee and medical specialty descriptions during the FDA review process.

• Is there any information provided about the availability of different sizes or models for this dialyzer?

  The data includes multiple registration numbers (e.g., 1721676, 6898, etc.) which may correspond to different models or variations of the COBE CENTRYSYSTEM Hollow Fiber Dialyzers, but no explicit details about specific sizes, models, or their differences are provided. For precise size or model information, consulting the manufacturer’s catalog or additional documentation is recommended.