Modified Am-Series Dialyzers
FDA 510(k) K892375 · Asahi Medical Co., Ltd.
510(k) numberK892375
Submission
- Device name
- Modified Am-Series Dialyzers
- Applicant
- Asahi Medical Co., Ltd.
Washington, DC, US - Received
- March 31, 1989
- Decision date
- May 18, 1989
- 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 |
|---|---|---|
| K041726 | High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer, Models…KDI · Special | 07/23/2004SE |
| K013418 | Am-Bio Extended Range Series Dialyzer, Models Wet and DryKDI · Traditional | 07/09/2002SE |
| K001250 | Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models)KDI · Traditional | 08/16/2000SE |
| K991512 | Asahi Am-R-Series Dialyzers (Modified), Model Am-Nr-XFJI · Traditional | 07/29/1999SE |
| K983720 | Asahi Am-Bio Series Dialyzers (Wet Models)& (Dry Models), Models AM-BIO-50,AM-BIO-65…MSE · Traditional | 05/17/1999SE |
| K970650 | Asahi Am-R Series DialyzersMSE · Traditional | 09/30/1997SE |
| K914020 | Modified Asahi Pan-Series HemofiltersKDI · Traditional | 03/20/1992SE |
| K901887 | Modified Sepacell R-Series Blood FiltersCAK · Traditional | 08/08/1990SE |
| K896976 | Modified Sepacell R-500 and R-500A Blood FiltersCAK · Traditional | 01/24/1990SE |
| K896664 | Modified Sepacell Pl-Series Leukocyte Removal FiltCAK · Traditional | 01/24/1990SE |
Questions and answers
When was Modified Am-Series Dialyzers cleared by the FDA?
Modified Am-Series Dialyzers (K892375) received a 510(k) decision of Substantially Equivalent on May 18, 1989, 48 days after the submission was received.
What is the product code of K892375?
The FDA product code is FJI – Dialyzer, Capillary, Hollow Fiber, a Class II (moderate risk) device regulated under 21 CFR 876.5820.