Cobe Arylane H1, H4, H6 & H9 Hemodialyzers/Filters
FDA 510(k) K982413 · Gambro Healthcare
510(k) numberK982413
Submission
- Device name
- Cobe Arylane H1, H4, H6 & H9 Hemodialyzers/Filters
- Applicant
- Gambro Healthcare
Lakewood, CO, US - Received
- July 13, 1998
- Decision date
- April 21, 1999
- 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 |
|---|---|---|
| K994390 | Gambro Polyflux 17R, Capillary Dialyzer/ FilterMSF · Traditional | 10/26/2000SE |
| K990039 | Gambro DQM 200LFP · Traditional | 01/27/2000SE |
| K982414 | Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ HemofiltersKDI · Traditional | 03/26/1999SE |
| K980386 | Hospal Multiflow 100, Multiflow 100 Kits A0 (A0,A0/B and A0/0), Multiflow 100 Kits B22…KDI · Traditional | 02/24/1999SE |
| K982760 | Cobe C Hemodialysis Delivery System , Cobe Cartridge Blood Tubing SetKDI · Traditional | 11/04/1998SE |
| K982818 | Hospal TipstopKMF · Traditional | 10/21/1998SE |
| K974899 | Gambro Central Water Treatment System CWP 100 - Wro HFIP · Traditional | 09/23/1998SE |
| K981681 | Prisma CFM (Continuous Fluid Management System)KDI · Traditional | 08/11/1998SE |
| K981085 | Gambro Hemodialysis Water Treatment SystemFIP · Traditional | 05/18/1998SE |
| K970253 | Cobe Centrysystem 3 Dialysis Control Unit/Cobe Cartridge Blood Tubing SetKDI · Traditional | 09/26/1997SE |
Questions and answers
When was Cobe Arylane H1, H4, H6 & H9 Hemodialyzers/Filters cleared by the FDA?
Cobe Arylane H1, H4, H6 & H9 Hemodialyzers/Filters (K982413) received a 510(k) decision of Substantially Equivalent on April 21, 1999, 282 days after the submission was received.
What is the product code of K982413?
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.