Erika HPF 300

FDA 510(k) K791322 · Erika, Inc.

Substantially Equivalent

510(k) numberK791322

Submission

Device name
Erika HPF 300
Applicant
Erika, Inc.
Mchenry, IL, US
Received
July 12, 1979
Decision date
September 24, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FJI – Dialyzer, Capillary, Hollow Fiber
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5820
Specialty
Gastroenterology, Urology
Life-sustaining
Yes

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K043342Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L…FJI · Traditional Gambro Renal Products05/27/2005SE
K010366Disposable Storage CapFJI · Abbreviated Molded Products, Inc.11/28/2001SE
K011148Ultraconcentrator SystemFJI · Special Interpore Cross Intl.06/13/2001SE
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K991908Idemsa Hemophan Hollow Fiber DialyzersFJI · Traditional Idemsa04/17/2000SE
K992594A-15 HemodialyzerFJI · Traditional Althin Medical AB09/24/1999SE
K992565A-18 HemodialyzerFJI · Traditional Althin Medical AB09/23/1999SE
K991512Asahi Am-R-Series Dialyzers (Modified), Model Am-Nr-XFJI · Traditional Asahi Medical Co., Ltd.07/29/1999SE

More from Asahi Medical Co., Ltd.

510(k)DeviceDecision
K853134National Med Care Infusion Pump Adm Set #95-0001-8FRN · Traditional 11/06/1985SE
K852310Naturalyte Bicarbonate Concentrate-Dry PackFKQ · Traditional 07/26/1985SE
K852309Erika Art Li, 3-9621-8, 22-6, 23-4 & Ven 9714-1FJK · Traditional 07/26/1985SE
K850866Toray Industries Filtryzer Hollow Fiber Kidney B1LKDI · Traditional 04/03/1985SE
K850865Toray Industries Filtryzer Hollow Fiber Kidney B1-FJI · Traditional 04/03/1985SE
K850655Toray Ind. Filtryzer Hollow Fiber Artif. Kidney B2FJI · Traditional 03/07/1985SE
K850654Toray Indus. Filtryzer Hollow Fiber Artificial KidFJI · Traditional 03/07/1985SE
K842436Erika Negative Press. Arterial BloodKOC · Traditional 07/13/1984SE
K831176Filtryzer Hollow Fiber Artif. KidneyKOC · Traditional 06/22/1984SE
K831175Filtryzer Hollow Fiber Artif. KidneyKOC · Traditional 06/22/1984SE

Questions and answers

When was Erika HPF 300 cleared by the FDA?

Erika HPF 300 (K791322) received a 510(k) decision of Substantially Equivalent on September 24, 1979, 74 days after the submission was received.

What is the product code of K791322?

The FDA product code is FJI – Dialyzer, Capillary, Hollow Fiber, a Class II (moderate risk) device regulated under 21 CFR 876.5820.