Catheter Bubble Stand
FDA 510(k) K813487 · Accurate Surgical Instruments Co.
510(k) numberK813487
Submission
- Device name
- Catheter Bubble Stand
- Applicant
- Accurate Surgical Instruments Co.
Walker, MI, US - Received
- December 1, 1981
- Decision date
- December 31, 1981
- 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 |
|---|---|---|
| K950042 | Swan Neck Presternal Peritoneal Dialysis CatheterFJS · Traditional | 12/15/1995SE |
| K920515 | InsertionFJS · Traditional | 05/04/1992SE |
| K910786 | Trocar (Faller Stylet)FJS · Traditional | 09/19/1991SE |
| K910785 | Titanium Catheter ExtenderFJS · Traditional | 08/22/1991SE |
| K910787 | Titanium Connector (2 Part)FKO · Traditional | 08/15/1991SE |
| K862046 | Swan-Neck Peritoneal Dialysis CathetersFJS · Traditional | 06/19/1986SE |
| K850214 | Sterile Catheters-Catheter Peritoneal Long-Term inFJS · Traditional | 07/26/1985SE |
| K813488 | Catheter RegularFJS · Traditional | 12/31/1981SE |
Questions and answers
When was Catheter Bubble Stand cleared by the FDA?
Catheter Bubble Stand (K813487) received a 510(k) decision of Substantially Equivalent on December 31, 1981, 30 days after the submission was received.
What is the product code of K813487?
The FDA product code is FKX – System, Peritoneal, Automatic Delivery, a Class II (moderate risk) device regulated under 21 CFR 876.5630.