Erika HPF 100,200,300 Dialyzer
FDA 510(k) K821690 · Erika, Inc.
510(k) numberK821690
Submission
- Device name
- Erika HPF 100,200,300 Dialyzer
- Applicant
- Erika, Inc.
Mchenry, IL, US - Received
- June 8, 1982
- Decision date
- June 22, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
Other 510(k)s with product code FJI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K190459 | Hemoflow F3 and F4 DialyzersFJI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 08/23/2019SE |
| K122952 | Nipro Pureflux-L HemodialyzerFJI · Traditional | Nipro Medical Corporation | 12/04/2013SE |
| K043342 | Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L…FJI · Traditional | Gambro Renal Products | 05/27/2005SE |
| K010366 | Disposable Storage CapFJI · Abbreviated | Molded Products, Inc. | 11/28/2001SE |
| K011148 | Ultraconcentrator SystemFJI · Special | Interpore Cross Intl. | 06/13/2001SE |
| K002761 | Fresnius Hemoflow F7NR, F50NR, F70NR HemodialyzersFJI · Traditional | Fresenius Medical Care North America | 12/04/2000SE |
| K991908 | Idemsa Hemophan Hollow Fiber DialyzersFJI · Traditional | Idemsa | 04/17/2000SE |
| K992594 | A-15 HemodialyzerFJI · Traditional | Althin Medical AB | 09/24/1999SE |
| K992565 | A-18 HemodialyzerFJI · Traditional | Althin Medical AB | 09/23/1999SE |
| K991512 | Asahi 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) | Device | Decision |
|---|---|---|
| K853134 | National Med Care Infusion Pump Adm Set #95-0001-8FRN · Traditional | 11/06/1985SE |
| K852310 | Naturalyte Bicarbonate Concentrate-Dry PackFKQ · Traditional | 07/26/1985SE |
| K852309 | Erika Art Li, 3-9621-8, 22-6, 23-4 & Ven 9714-1FJK · Traditional | 07/26/1985SE |
| K850866 | Toray Industries Filtryzer Hollow Fiber Kidney B1LKDI · Traditional | 04/03/1985SE |
| K850865 | Toray Industries Filtryzer Hollow Fiber Kidney B1-FJI · Traditional | 04/03/1985SE |
| K850655 | Toray Ind. Filtryzer Hollow Fiber Artif. Kidney B2FJI · Traditional | 03/07/1985SE |
| K850654 | Toray Indus. Filtryzer Hollow Fiber Artificial KidFJI · Traditional | 03/07/1985SE |
| K842436 | Erika Negative Press. Arterial BloodKOC · Traditional | 07/13/1984SE |
| K831176 | Filtryzer Hollow Fiber Artif. KidneyKOC · Traditional | 06/22/1984SE |
| K831175 | Filtryzer Hollow Fiber Artif. KidneyKOC · Traditional | 06/22/1984SE |
Questions and answers
When was Erika HPF 100,200,300 Dialyzer cleared by the FDA?
Erika HPF 100,200,300 Dialyzer (K821690) received a 510(k) decision of Substantially Equivalent on June 22, 1982, 14 days after the submission was received.
What is the product code of K821690?
The FDA product code is FJI – Dialyzer, Capillary, Hollow Fiber, a Class II (moderate risk) device regulated under 21 CFR 876.5820.