Amicon Diafilters 20 & 30 Hemofilters
FDA 510(k) K823288 · Amicon, Inc.
510(k) numberK823288
Submission
- Device name
- Amicon Diafilters 20 & 30 Hemofilters
- Applicant
- Amicon, Inc.
Walker, MI, US - Received
- November 4, 1982
- Decision date
- December 16, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K930168 | Centricon -50 ConcentratorJJH · Traditional | 08/05/1993SE |
| K902837 | Amicon Diafilter 30 HemoconcentratorKDI · Traditional | 11/01/1990SE |
| K901286 | Amicon Hemoconcentrator SetKDI · Traditional | 05/18/1990SE |
| K900280 | Centriprep 100JJP · Traditional | 02/16/1990SE |
| K895405 | Amicon Minifilter Plus HemofilterKDI · Traditional | 01/11/1990SE |
| K893733 | Centricon ConcentratorJJH · Traditional | 07/20/1989SE |
| K892645 | Amicon Vitafiber Flo-Path Biorect/Vls Cell Cult SyKJF · Traditional | 06/13/1989SE |
| K875121 | Amicon Equaline Fluid Balance SystemKPF · Traditional | 02/19/1988SE |
| K870690 | Centriprep ConcentratorJJH · Traditional | 03/19/1987SE |
| K863823 | Amicon Diafilter HemofilterKDI · Traditional | 11/06/1986SE |
Questions and answers
When was Amicon Diafilters 20 & 30 Hemofilters cleared by the FDA?
Amicon Diafilters 20 & 30 Hemofilters (K823288) received a 510(k) decision of Substantially Equivalent on December 16, 1982, 42 days after the submission was received.
What is the product code of K823288?
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.