Capd - Catheter Adapter
FDA 510(k) K831716 · American Mcgaw
510(k) numberK831716
Submission
- Device name
- Capd - Catheter Adapter
- Applicant
- American Mcgaw
Mchenry, IL, US - Received
- May 27, 1983
- Decision date
- June 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 |
|---|---|---|
| K853549 | Mcgaw/Drop Watch Flow MonitorFLN · Traditional | 11/12/1985SE |
| K843639 | Add-A-Vial Solution Transfer DeviceLHI · Traditional | 01/14/1985SE |
| K843954 | Mixing ContainerKPE · Traditional | 11/28/1984SE |
| K841729 | Accupro Enteral Feeding PumpFRN · Traditional | 06/01/1984SE |
| K840388 | Pab IV ContainerKPE · Traditional | 03/06/1984SE |
| K840212 | Concentrated Platelet Admin. SetFPA · Traditional | 03/06/1984SE |
| K822240 | Ethylene Oxide Steriliz. Parametric Rel.KFX · Traditional | 12/30/1982SE |
| K820133 | Mcgaw Fat Emulsion SetFPA · Traditional | 04/06/1982SE |
| K813092 | Accupro I.V. Administration SetFPA · Traditional | 12/31/1981SE |
| K810683 | Capd Catheter AdapterFKX · Traditional | 05/08/1981SE |
Questions and answers
When was Capd - Catheter Adapter cleared by the FDA?
Capd - Catheter Adapter (K831716) received a 510(k) decision of Substantially Equivalent on June 24, 1983, 28 days after the submission was received.
What is the product code of K831716?
The FDA product code is FKX – System, Peritoneal, Automatic Delivery, a Class II (moderate risk) device regulated under 21 CFR 876.5630.