Filtral 10, Filtral 12, Filtral 16 Hemodialyzer
FDA 510(k) K872767 · Hospal Medical Corp.
510(k) numberK872767
Submission
- Device name
- Filtral 10, Filtral 12, Filtral 16 Hemodialyzer
- Applicant
- Hospal Medical Corp.
Edison, NJ, US - Received
- July 14, 1987
- Decision date
- December 29, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K893742 | Filtral TM 20 Hemodialyzer/FilterKDI · Traditional | 07/24/1989SE |
| K884365 | Multiflow(Tm) 60 KitKDI · Traditional | 12/08/1988SE |
| K884326 | Filtral TM 8 HemodialyzerKDI · Traditional | 12/05/1988SE |
| K883307 | Cardioflow 100 Hemoconcentrator/Preparation KitKDI · Traditional | 10/12/1988SE |
| K871218 | Monitral S GS Hemodialysis Single Patient UnitFKP · Traditional | 04/30/1987SE |
| K863961 | Hospal Biospal 1800SKDI · Traditional | 12/17/1986SE |
| K863592 | Disscap 80E, 110E, 140E, 160EFJI · Traditional | 09/25/1986SE |
| K861156 | Hospal Dialysate for CavhdKPO · Traditional | 09/23/1986SE |
| K861230 | Monitral SFKP · Traditional | 04/25/1986SE |
| K854951 | Plume Y SetFIE · Traditional | 01/08/1986SE |
Questions and answers
When was Filtral 10, Filtral 12, Filtral 16 Hemodialyzer cleared by the FDA?
Filtral 10, Filtral 12, Filtral 16 Hemodialyzer (K872767) received a 510(k) decision of Substantially Equivalent on December 29, 1987, 168 days after the submission was received.
What is the product code of K872767?
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.