DBB-06 Hemodialysis Delivery System
FDA 510(k) K091978 · Nikkiso Co., Ltd.
510(k) numberK091978
Submission
- Device name
- DBB-06 Hemodialysis Delivery System
- Applicant
- Nikkiso Co., Ltd.
Tokyo, JP - Received
- July 1, 2009
- Decision date
- March 25, 2010
- 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
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| 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 |
|---|---|---|
| K242479 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR…KOC · Traditional | 05/15/2025SE |
| K242176 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR…KOC · Traditional | 05/15/2025SE |
| K242155 | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)KDI · Traditional | 05/15/2025SE |
| K231589 | Blood Tubing Lines for Hemodialysis AV06C-EKOC · Traditional | 07/28/2023SE |
| K230514 | Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for…KOC · Traditional | 06/16/2023SE |
| K152938 | DBB-06 Hemodialysis Delivery SystemKDI · Traditional | 03/18/2016SE |
| K082719 | Nikkline Blood Tubing Lines with Transducer Protectors, Models AV06A-P, AVO6B-P, AV06C-PKOC · Traditional | 03/30/2009SE |
| K061519 | Modification to DBB-05 Hemodialysis Delivery SystemKDI · Special | 09/28/2007SE |
| K953996 | Nikkiso Co, Ltd., FLX10GW, 12GW, 15GW, 18GW & 21GW HemodialyzersKDI · Traditional | 03/19/1997SE |
| K803068 | Nikkiso ND-14 Parallel Flow DialyzerFJG · Traditional | 03/04/1981SE |
Questions and answers
When was DBB-06 Hemodialysis Delivery System cleared by the FDA?
DBB-06 Hemodialysis Delivery System (K091978) received a 510(k) decision of Substantially Equivalent on March 25, 2010, 267 days after the submission was received.
What is the product code of K091978?
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.