Delmed 80/2 Dialysis System W/Ultrafiltration
FDA 510(k) K901477 · Delmed, Inc.
510(k) numberK901477
Submission
- Device name
- Delmed 80/2 Dialysis System W/Ultrafiltration
- Applicant
- Delmed, Inc.
Concord, CA, US - Received
- March 27, 1990
- Decision date
- July 27, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FKX – System, Peritoneal, Automatic Delivery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5630
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FKX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250523 | Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard…FKX · Traditional | Simergent, LLC | 10/02/2025SE |
| K243371 | Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1FKX · Traditional | Byonyks Pvt, Ltd. | 05/16/2025SE |
| K220935 | Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision…FKX · Traditional | Iren-Medical, Ltd. | 12/29/2022SE |
| K222318 | Fresenius Liberty Select CyclerFKX · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 10/31/2022SE |
| K212522 | Lilliput APD SystemFKX · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 04/15/2022SE |
| K212658 | CloudCath Peritoneal Dialysis Drain Set Monitoring SystemFKX · Traditional | Cloudcath | 02/09/2022SE |
| K201867 | Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the…FKX · Traditional | Baxter Healthcare Corporation | 11/19/2020SE |
| K181108 | Fresenius Liberty Select CyclerFKX · Special | Fresenius Medical Care Renal Therapies Group, LLC | 05/24/2018SE |
| K173718 | Liberty Cycler SetFKX · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/01/2018SE |
| K171652 | Fresenius Liberty Select CyclerFKX · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 09/15/2017SE |
More from Fresenius Medical Care Renal Therapies Group, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K895650 | Enteral Pump Set W/Entera-Flo SpikeKNT · Traditional | 10/02/1990SE |
| K895329 | 600ML and 1200ML Enteral Bag Adm. Set for EnteraKNT · Traditional | 10/02/1990SE |
| K895142 | Enteral Pump Set with Enteral SpikeKNT · Traditional | 10/02/1990SE |
| K894506 | Entera-Flo Enteral Feeding PumpFRN · Traditional | 08/06/1990SE |
| K901478 | Delmed 80/2 Dialysis System W/Last Bag OptionFKX · Traditional | 07/27/1990SE |
| K900106 | Closed Disconnect SystemKDJ · Traditional | 07/16/1990SE |
| K895933 | Enteral Pump Sets for Use with Ross Flexiflo-IiiKNT · Traditional | 05/02/1990SE |
| K895919 | Enteral Bag Admini. Sets for Use W/Flexiflo-IiiKNT · Traditional | 05/02/1990SE |
| K895696 | Enteral Pump Set W/Enteral Spike for Use W/Feed PuKNT · Traditional | 05/02/1990SE |
| K895330 | 600ML and 1200ML Enteral Bag Adm. Set for FrentaKNT · Traditional | 05/02/1990SE |
Questions and answers
When was Delmed 80/2 Dialysis System W/Ultrafiltration cleared by the FDA?
Delmed 80/2 Dialysis System W/Ultrafiltration (K901477) received a 510(k) decision of Substantially Equivalent on July 27, 1990, 122 days after the submission was received.
What is the product code of K901477?
The FDA product code is FKX – System, Peritoneal, Automatic Delivery, a Class II (moderate risk) device regulated under 21 CFR 876.5630.