Amia Automated PD System
FDA 510(k) K124018 · Deka Research & Development Corp.
510(k) numberK124018
Submission
- Device name
- Amia Automated PD System
- Applicant
- Deka Research & Development Corp.
Manchester, NH, US - Received
- December 27, 2012
- Decision date
- June 14, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K250930 | twiist systemQFG · Special | 04/02/2025SE |
| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) InjectionFRN · Special | 03/11/2025SE |
| K243354 | Remunity SystemQJY · Special | 11/27/2024SE |
| K191313 | Unity Subcutaneous Infusion System for RemodulinQJY · Traditional | 02/21/2020SE |
| K190182 | Unity Subcutaneous Delivery System for RemodulinFRN · Traditional | 05/06/2019SE |
| K172601 | Next Generation iBOTIMK · Traditional | 03/02/2018SE |
| K153760 | Volumetric Infusion ControllerLDR · Traditional | 10/03/2016SE |
| K093915 | Deka Tac DeviceFIG · Traditional | 08/23/2011SE |
| K103220 | Voyager Peritoneal Dialysis SystemFKX · Traditional | 07/29/2011SE |
| K863204 | Deka Jr.LDR · Traditional | 09/03/1986SE |
Questions and answers
When was Amia Automated PD System cleared by the FDA?
Amia Automated PD System (K124018) received a 510(k) decision of Substantially Equivalent on June 14, 2013, 169 days after the submission was received.
What is the product code of K124018?
The FDA product code is FKX – System, Peritoneal, Automatic Delivery, a Class II (moderate risk) device regulated under 21 CFR 876.5630.