Hospal Biospal 1800S
FDA 510(k) K863961 · Hospal Medical Corp.
510(k) numberK863961
Submission
- Device name
- Hospal Biospal 1800S
- Applicant
- Hospal Medical Corp.
East Brunswick, NJ, US - Received
- October 10, 1986
- Decision date
- December 17, 1986
- 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
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| 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 |
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| 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 |
| K872767 | Filtral 10, Filtral 12, Filtral 16 HemodialyzerKDI · Traditional | 12/29/1987SE |
| K871218 | Monitral S GS Hemodialysis Single Patient UnitFKP · Traditional | 04/30/1987SE |
| 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 Hospal Biospal 1800S cleared by the FDA?
Hospal Biospal 1800S (K863961) received a 510(k) decision of Substantially Equivalent on December 17, 1986, 68 days after the submission was received.
What is the product code of K863961?
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.