Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models)
FDA 510(k) K001250 · Asahi Medical Co., Ltd.
510(k) numberK001250
Submission
- Device name
- Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models)
- Applicant
- Asahi Medical Co., Ltd.
Rockville, MD, US - Received
- April 19, 2000
- Decision date
- August 16, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code KDI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261267 | Careflux H60;Careflux H70;Careflux V500KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 07/24/2026SE |
| K252377 | NxStage System One with NxViewKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/15/2026SE |
| K260533 | Elisio-HKDI · Special | Nipro Medical Corporation | 03/19/2026SE |
| K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124)KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 02/10/2026SE |
| K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U)KDI · Traditional | Outset Medical, Inc. | 01/26/2026SE |
| K253518 | FX CorAL 40; FX CorAL 50KDI · Special | Fresenius Medical Care Renal Therapies Group, LLC | 12/18/2025SE |
| K243920 | Purema H Hemoconcentrator - PediatricKDI · Traditional | Medica USA, Inc. | 09/19/2025SE |
| K250508 | AK 98 Dialysis Machine (955607)KDI · Traditional | Vantive US Healthcare, LLC | 08/01/2025SE |
| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T…KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 06/13/2025SE |
| K243505 | 5008X Hemodialysis SystemKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/30/2025SE |
More from Fresenius Medical Care Renal Therapies Group, LLC
| 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 |
| 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 |
| K892375 | Modified Am-Series DialyzersFJI · Traditional | 05/18/1989SE |
Questions and answers
When was Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models) cleared by the FDA?
Aps Series Dialyzers (Wet Models), Aps Series Dialysis (Dry Models) (K001250) received a 510(k) decision of Substantially Equivalent on August 16, 2000, 119 days after the submission was received.
What is the product code of K001250?
The FDA product code is KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System, a Class II (moderate risk) device regulated under 21 CFR 876.5860.