Beta-Cap D Adapter
FDA 510(k) K830208 · Quinton, Inc.
510(k) numberK830208
Submission
- Device name
- Beta-Cap D Adapter
- Applicant
- Quinton, Inc.
Walker, MI, US - Received
- January 21, 1983
- Decision date
- March 7, 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 |
|---|---|---|
| K032038 | Pyramis ECG Management System Model Numbers, 92600 and 92601DQK · Abbreviated | 09/05/2003SE |
| K021906 | Quinton Q-Cath, Model 000460DQK · Abbreviated | 09/04/2002SE |
| K003576 | Q-Tel RMS (Rehabilitation Management System), Model 000503DSI · Abbreviated | 01/25/2001SE |
| K001492 | Quinton Q-Stress, Model 000483DPS · Abbreviated | 08/09/2000SE |
| K992908 | Q-Tel Telemetry System V. 6.0 (ST)DSI · Traditional | 03/06/2000SE |
| K990866 | Quinton Medtrack CR Plus TreadmillISD · Traditional | 04/29/1999SE |
| K971397 | Viewcath 3-D Catheter PullbackITX · Traditional | 08/25/1997SE |
| K964784 | Synergy Cardiology Information System (00431)DPS · Traditional | 08/13/1997SE |
| K964978 | Vital Statistics System (O-Cath Accessory)DQA · Traditional | 05/21/1997SE |
| K955002 | Mahurkar 8 FR Dual Lemen CatheterMPB · Traditional | 09/13/1996SE |
Questions and answers
When was Beta-Cap D Adapter cleared by the FDA?
Beta-Cap D Adapter (K830208) received a 510(k) decision of Substantially Equivalent on March 7, 1983, 45 days after the submission was received.
What is the product code of K830208?
The FDA product code is FKX – System, Peritoneal, Automatic Delivery, a Class II (moderate risk) device regulated under 21 CFR 876.5630.