PC 201A Locking Sleeve
FDA 510(k) K823390 · Medigroup
510(k) numberK823390
Submission
- Device name
- PC 201A Locking Sleeve
- Applicant
- Medigroup
Mchenry, IL, US - Received
- November 5, 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 |
|---|---|---|
| K120130 | Faller TrocarFJS · Traditional | 05/21/2012SE |
| K071167 | Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560FJS · Traditional | 08/31/2007SESK |
| K070730 | Flex-Neck Arc CatheterFJS · Traditional | 07/03/2007SESK |
| K060897 | Embedding Tool, Model TE-1000FJS · Traditional | 07/18/2006SE |
| K031351 | Flex-Neck PD Catheter, InfantFJS · Traditional | 09/17/2003SE |
| K974570 | Peritoneal Dialysis Catheter ConnectorFKO · Traditional | 02/27/1998SE |
| K823294 | Medigroup LS-110 Light SourceHET · Traditional | 05/09/1983SE |
| K823297 | ST-610 Needlescope Sterilization TrayHET · Traditional | 05/06/1983SE |
| K823295 | Medigroup 2.2MM Needlescope Cannula&HET · Traditional | 05/06/1983SE |
| K823293 | Medigroup LG-102 Light GuideHET · Traditional | 05/05/1983SE |
Questions and answers
When was PC 201A Locking Sleeve cleared by the FDA?
PC 201A Locking Sleeve (K823390) received a 510(k) decision of Substantially Equivalent on January 26, 1983, 82 days after the submission was received.
What is the product code of K823390?
The FDA product code is FKX – System, Peritoneal, Automatic Delivery, a Class II (moderate risk) device regulated under 21 CFR 876.5630.