Impra Peritoneal Catheter
FDA 510(k) K823857 · Impra, Inc.
510(k) numberK823857
Submission
- Device name
- Impra Peritoneal Catheter
- Applicant
- Impra, Inc.
Walker, MI, US - Received
- December 22, 1982
- Decision date
- January 26, 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 |
|---|---|---|
| K004012 | Impra Carboflo Eptfe Vascular GraftsDYF · Traditional | 05/14/2001SE |
| K004011 | Impra Carboflo Vascular Graft, Impra Carboflo Vascular Grafts for A-V AccessDSY · Traditional | 03/27/2001SE |
| K991027 | Bi-Directional TunnelerDSY · Special | 04/22/1999SE |
| K983769 | Distaflo Bypass GraftDYF · Abbreviated | 12/15/1998SE |
| K983861 | Distaflo Bypass GraftDSY · Abbreviated | 11/24/1998SE |
| K983064 | Impra High Porosity GraftDSY · Traditional | 11/19/1998SE |
| K981079 | Venaflo PTFE Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular GraftDSY · Traditional | 05/07/1998SE |
| K981076 | Venaflo PTFE Vascular Graft, Venaflo Graft with Carbon, Venaflo Vascular GraftDYF · Traditional | 05/07/1998SE |
| K971192 | Impra Eptfe Arteriovenous Cuffed GraftDSY · Traditional | 04/15/1997ST |
| K964877 | Impra Eptfe Arteriovenous Cuffed GraftDYF · Traditional | 03/20/1997ST |
Questions and answers
When was Impra Peritoneal Catheter cleared by the FDA?
Impra Peritoneal Catheter (K823857) received a 510(k) decision of Substantially Equivalent on January 26, 1983, 35 days after the submission was received.
What is the product code of K823857?
The FDA product code is FKX – System, Peritoneal, Automatic Delivery, a Class II (moderate risk) device regulated under 21 CFR 876.5630.