System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration Set
FDA 510(k) K013733 · Chf Solutions, Inc.
510(k) numberK013733
Submission
- Device name
- System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration Set
- Applicant
- Chf Solutions, Inc.
Washington, DC, US - Received
- November 9, 2001
- Decision date
- June 3, 2002
- 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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| K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124)KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 02/10/2026SE |
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| 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 |
|---|---|---|
| K192756 | Aquadex FlexFlow System 2.0KDI · Traditional | 02/24/2020SE |
| K071854 | Aquadex Flexflow SystemKDI · Special | 09/07/2007SE |
| K070512 | Modification to Aquadex Flexflow SystemKDI · Special | 04/27/2007SE |
| K062922 | Modification to Aquadex Flexflow SystemKDI · Special | 12/13/2006SE |
| K060008 | Aquadex Flexflow SystemKDI · Special | 02/02/2006SE |
| K050609 | Aquadex SystemKDI · Traditional | 11/09/2005SE |
| K041791 | 5.2F Dual Lumen Extended Length Catheter (Delc)NQJ · Traditional | 09/10/2004SE |
| K040489 | Aquadex System 100, Model A1100KDI · Special | 04/27/2004SE |
| K031689 | Dual Lumen Extended Length Catheter (Delc)NQJ · Traditional | 12/23/2003SE |
| K023874 | System 100 Ultrafiltration CatheterKDI · Traditional | 11/20/2003SE |
Questions and answers
When was System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration Set cleared by the FDA?
System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration Set (K013733) received a 510(k) decision of Substantially Equivalent on June 3, 2002, 206 days after the submission was received.
What is the product code of K013733?
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.