Altra Flux 110 Hemodialyzer
FDA 510(k) K952978 · Althin Medical AB an Affiliate of Baxter Intl
510(k) numberK952978
Submission
- Device name
- Altra Flux 110 Hemodialyzer
- Applicant
- Althin Medical AB an Affiliate of Baxter Intl
Miami Lakes, FL, US - Received
- June 27, 1995
- Decision date
- October 5, 1995
- 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
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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 |
|---|---|---|
| K990643 | PS 15 Polysulfone Hollow Fiber Membrane Hemodialyzer, Model 239-015KDI · Traditional | 12/07/1999SE |
| K970681 | Altra Nova 200 HemodialyzerMSF · Traditional | 07/23/1998SE |
| K970679 | Altra Flux 200 HemodialyzerMSF · Traditional | 07/23/1998SE |
| K970446 | Drake Willock System & Altra Touch 1000 Dialysis Delivery SystemKDI · Traditional | 06/02/1997SE |
| K964922 | Drake Willock System 1000 Dialysate Delivery System Altratouch 1000 Dialysate Delivery…KDI · Traditional | 05/21/1997SE |
| K955384 | Drake Willock System 1000 Dialysate Delivery System W/Single Needle Single Lumen OptionKDI · Traditional | 01/10/1997SE |
| K962309 | Alternate Encapsulating Resin System for Mca HemodialyzersFJI · Traditional | 12/27/1996SE |
| K954987 | Altratouch 1000 Hemodialysis Delivery SystemKDI · Traditional | 08/08/1996SE |
| K952983 | Altr Nova 110 HemodialyzerKDI · Traditional | 10/05/1995SE |
| K952982 | Altrex 110 HemodialyzerKDI · Traditional | 10/05/1995SE |
Questions and answers
When was Altra Flux 110 Hemodialyzer cleared by the FDA?
Altra Flux 110 Hemodialyzer (K952978) received a 510(k) decision of Substantially Equivalent on October 5, 1995, 100 days after the submission was received.
What is the product code of K952978?
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.