Modification to Kidney Dialyzer

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K771349 ↗

FDA Product Code

FHS

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Erika Hpf 100

  Class II

  FDA 510(k) K791320 Active Cleared 24 Sep 1979

• Micro-Coil 100 Coil Dialyzer

  Class II

  FDA 510(k) K800723 Active Cleared 14 May 1980

• Erika Hpf 300

  Class II

  FDA 510(k) K791322 Active Cleared 24 Sep 1979

• Toray Ind. Filtryzer Hollow Fiber Artif. Kidney B2

  Class II

  FDA 510(k) K850655 Active Cleared 7 Mar 1985

• National Med Care Infusion Pump Adm Set #95-0001-8

  Class II

  FDA 510(k) K853134 Active Cleared 6 Nov 1985

• Dialyzer, Magniflo 100 Parallel Plate

  Class II

  FDA 510(k) K781966 Active Cleared 21 Feb 1979

See all devices from Erika, Inc. →