FB-U Hemodialyzer
FDA 510(k) K160444 · Nipro Medical Corporation
510(k) numberK160444
Submission
- Device name
- FB-U Hemodialyzer
- Applicant
- Nipro Medical Corporation
Miami, FL, US - Received
- February 17, 2016
- Decision date
- February 8, 2017
- 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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| 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 |
|---|---|---|
| K261399 | Elisio-HxQAX · Traditional | 07/28/2026SE |
| K253047 | PressoneFMI · Traditional | 03/24/2026SE |
| K260533 | Elisio-HKDI · Special | 03/19/2026SE |
| K222852 | Nipro SafeTouch Needle; Nipro Syringe with SafeTouch NeedleFMI · Traditional | 05/25/2023SE |
| K212677 | aboNT SYRINGEFMF · Traditional | 04/15/2022SE |
| K190037 | Cronus HP PTA Balloon CatheterLIT · Traditional | 10/24/2019SE |
| K191359 | Nipro SyringeFMF · Traditional | 10/09/2019SE |
| K182940 | Surdial DX Hemodialysis SystemKDI · Traditional | 07/19/2019SE |
| K173029 | Nipro SyringeFMF · Traditional | 03/30/2018SE |
| K161681 | Nipro SafeTouch IV CatheterFOZ · Traditional | 03/08/2017SE |
Questions and answers
When was FB-U Hemodialyzer cleared by the FDA?
FB-U Hemodialyzer (K160444) received a 510(k) decision of Substantially Equivalent on February 8, 2017, 357 days after the submission was received.
What is the product code of K160444?
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.