Easy Care and Tubing Sets
FDA 510(k) K994218 · Medionics International, Inc.
510(k) numberK994218
Submission
- Device name
- Easy Care and Tubing Sets
- Applicant
- Medionics International, Inc.
Markham, Ontario, CA - Received
- December 15, 1999
- Decision date
- February 10, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K130441 | Faller StyletFJS · Traditional | 04/19/2013SE |
| K993149 | Peritoneal Dialysis Catheters and AdaptersFJS · Traditional | 04/28/2000SE |
| K945567 | QC CapKDJ · Traditional | 02/07/1995SE |
| K910173 | Selectra and Tubing SetsFKX · Traditional | 01/13/1992SE |
| K883393 | Capd Disposable Y System - Dy SetKDJ · Traditional | 11/03/1988SE |
| K842305 | C.A.P.D. Automatic Heater PDH 200FKX · Traditional | 06/25/1984SE |
| K832141 | Microstar VC1 Volumetric CyclerFKX · Traditional | 10/14/1983SE |
| K831766 | Microstar VciFKX · Traditional | 10/14/1983SE |
| K821328 | C.A.P.D. Automatic Heater #Pdc 2000 HCPKPF · Traditional | 07/28/1982SE |
Questions and answers
When was Easy Care and Tubing Sets cleared by the FDA?
Easy Care and Tubing Sets (K994218) received a 510(k) decision of Substantially Equivalent on February 10, 2000, 57 days after the submission was received.
What is the product code of K994218?
The FDA product code is FKX – System, Peritoneal, Automatic Delivery, a Class II (moderate risk) device regulated under 21 CFR 876.5630.