Centry 2000 Dialysis Control Unit

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

510(k) Number

K840680 ↗

FDA Product Code

KDI

Device Class

Class II

Regulation

21 CFR Part 876.5860

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Cobe Laboratories, Inc. →

• What is the CENTRY 2000 DIALYSIS CONTROL UNIT used for?

  The CENTRY 2000 DIALYSIS CONTROL UNIT is designed for use in hemodialysis procedures to deliver dialysate during dialysis treatment, as specified in its intended use for single-patient dialysate delivery.

• Is the CENTRY 2000 DIALYSIS CONTROL UNIT reusable or single-use?

  The device is supplied as a reusable system, meaning it is intended for multiple uses after appropriate cleaning and reprocessing, not for single-use disposal.

• How was the CENTRY 2000 DIALYSIS CONTROL UNIT cleared for market?

  It was cleared through the FDA 510(k) process under clearance number K840680, with a decision date of April 20, 1984, based on a finding of substantial equivalence to a predicate device.

• What regulatory classification does the CENTRY 2000 DIALYSIS CONTROL UNIT have?

  The device is classified as a Class II medical device under product code KDI (System, Dialysate Delivery, Single Patient) and is subject to special controls as determined by the FDA.

• Who manufactures the CENTRY 2000 DIALYSIS CONTROL UNIT?

  The CENTRY 2000 DIALYSIS CONTROL UNIT is manufactured by Cobe Laboratories, Inc., located at 4221 Richmond Rd., NW, Walker, MI 49534, United States.