Non-Sterile Peritoneal Access Cathet-
FDA 510(k) K830257 · Evermed, Inc.
510(k) numberK830257
Submission
- Device name
- Non-Sterile Peritoneal Access Cathet-
- Applicant
- Evermed, Inc.
Mchenry, IL, US - Received
- January 25, 1983
- Decision date
- February 24, 1983
- 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 |
|---|---|---|
| K023993 | Galaxy Series WheelchairIOR · Traditional | 12/27/2002SE |
| K024030 | Millennium Series Manual WheelchairsIOR · Traditional | 12/12/2002SE |
| K023485 | Explorer Powered WheelchairITI · Traditional | 12/02/2002SE |
| K840846 | Sterile Hichman/Broviac Injection CapLJS · Traditional | 07/06/1984SE |
| K840529 | Steiger Tunneling Instrument 285DRC · Traditional | 03/12/1984SE |
| K830406 | Non-Sterile Catheter Repair KitsLJS · Traditional | 03/01/1983SE |
| K830256 | Non-Sterile Broviac Parenteral Alimi-LJS · Traditional | 03/01/1983SE |
| K830233 | Non-Sterile,Single/Souble Lumen-CathLJS · Traditional | 02/28/1983SE |
Questions and answers
When was Non-Sterile Peritoneal Access Cathet- cleared by the FDA?
Non-Sterile Peritoneal Access Cathet- (K830257) received a 510(k) decision of Substantially Equivalent on February 24, 1983, 30 days after the submission was received.
What is the product code of K830257?
The FDA product code is FKX – System, Peritoneal, Automatic Delivery, a Class II (moderate risk) device regulated under 21 CFR 876.5630.