Toraysulfone Dialyzer
FDA 510(k) K002512 · Toray Industries (America), Inc.
510(k) numberK002512
Submission
- Device name
- Toraysulfone Dialyzer
- Applicant
- Toray Industries (America), Inc.
Bellaire, TX, US - Received
- August 15, 2000
- Decision date
- October 15, 2001
- 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 |
|---|---|---|
| K042370 | Torayguide GuidewireDQX · Traditional | 12/17/2004SE |
| K030050 | Toraysulfone Dialyzer, Bs-L SeriesKDI · Traditional | 09/29/2003SE |
| K994198 | Hemofeel-Ch, Models CH-0.35L, CH-0.6L, CH-1.0LKDI · Traditional | 08/25/2000SE |
| K942681 | FiltryzerKDI · Traditional | 06/22/1995SE |
| K935471 | Filtryzer(Tm)FJI · Traditional | 05/19/1995SE |
| K940910 | FiltryzerFJI · Traditional | 05/04/1995SE |
| K884339 | Toray Filtryzer DialyzersFJI · Traditional | 03/17/1989SE |
| K883407 | Toray Filtryzer BK SeriesKDI · Traditional | 02/27/1989SE |
| K884083 | Toray Vascular ProsthesisDSY · Traditional | 01/12/1989SE |
| K882158 | Modified Toray Filtryzer DialyzersFJI · Traditional | 08/12/1988SE |
Questions and answers
When was Toraysulfone Dialyzer cleared by the FDA?
Toraysulfone Dialyzer (K002512) received a 510(k) decision of Substantially Equivalent on October 15, 2001, 426 days after the submission was received.
What is the product code of K002512?
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.