Amia Automated PD System with Sharesource
FDA 510(k) K151525 · Deka Research and Development
510(k) numberK151525
Submission
- Device name
- Amia Automated PD System with Sharesource
- Applicant
- Deka Research and Development
Manchester, NH, US - Received
- June 8, 2015
- Decision date
- October 9, 2015
- 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 |
|---|---|---|
| K261672 | twiist Automated Insulin Delivery (AID) SystemQFG · Special | 06/17/2026SE |
| K261530 | iiSure Infusion SetFPA · Special | 06/03/2026SE |
| K243841 | Sparta Infusion Set for InsulinFPA · Traditional | 08/01/2025SE |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) InjectionFRN · Traditional | 01/16/2025SE |
| K242693 | DEKA Infusion System, DEKA Administration SetLDR · Special | 10/07/2024SE |
| K240920 | HemoCare Bicarbonate Concentrate Set (BCS)KPO · Traditional | 07/12/2024SE |
| K233557 | HemoCare Hemodialysis SystemKDI · Traditional | 07/12/2024SE |
| K240256 | Remunity SystemQJY · Traditional | 06/12/2024SE |
| K241178 | DEKA ACE Pump SystemQFG · Special | 05/24/2024SE |
| K234055 | DEKA LoopQJI · Traditional | 03/13/2024SE |
Questions and answers
When was Amia Automated PD System with Sharesource cleared by the FDA?
Amia Automated PD System with Sharesource (K151525) received a 510(k) decision of Substantially Equivalent on October 9, 2015, 123 days after the submission was received.
What is the product code of K151525?
The FDA product code is FKX – System, Peritoneal, Automatic Delivery, a Class II (moderate risk) device regulated under 21 CFR 876.5630.