Peritoneal Dialysis Cycler Set (8UNIT)
FDA 510(k) K812772 · Dravon Medical, Inc.
510(k) numberK812772
Submission
- Device name
- Peritoneal Dialysis Cycler Set (8UNIT)
- Applicant
- Dravon Medical, Inc.
Mchenry, IL, US - Received
- October 5, 1981
- Decision date
- October 19, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDJ – Set, Administration, For Peritoneal Dialysis, Disposable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5630
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code KDJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250404 | staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter…KDJ · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 04/03/2025SE |
| K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended…KDJ · Traditional | Baxter Healthcare | 03/12/2024SE |
| K214016 | 15L Cycler Drainage BagKDJ · Traditional | Baxter Healthcare Corporation | 03/18/2022SE |
| K192705 | MiniCap Extended Life PD Transfer SetsKDJ · Special | Baxter Healthcare | 10/25/2019SE |
| K173593 | staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension…KDJ · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/21/2018SE |
| K173651 | Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain SetKDJ · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 02/14/2018SE |
| K173363 | Cycler Drain Bag SetKDJ · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 01/24/2018SE |
| K151620 | Firefly Peritoneal Dialysis Connector Disinfection SystemKDJ · Traditional | Puracath Medical, Inc. | 01/20/2016SE |
| K152675 | Extended Life Capd Transfer Set, Peritoneal Dialysis Titanium Catheter Adapter and…KDJ · Traditional | Baxter Healthcare | 10/29/2015SE |
| K152129 | FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine…KDJ · Traditional | Baxter Healthcare Corporation | 10/29/2015SE |
More from Baxter Healthcare Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K873455 | S3086 Arterial, S3087 Venous Neonatal HemodialysisFJK · Traditional | 09/14/1987SE |
| K860770 | AM-100 I/A AmpacHQC · Traditional | 04/21/1986SE |
| K832739 | Stediflo Infusion SetLDR · Traditional | 12/22/1983SE |
| K831842 | Dravon T ClampKDC · Traditional | 09/26/1983SE |
| K812771 | Peritoneal Dialysis DrainageKDJ · Traditional | 10/19/1981SE |
| K811851 | S-610 Shunt Adaptor SetKNR · Traditional | 08/31/1981SE |
| K800435 | Hemostatic/Tube Occluding ForcepsGEN · Traditional | 03/12/1980SE |
| K782058 | Catheter, Beta-Cap-PeritonealFJS · Traditional | 02/27/1979SE |
| K782057 | Catheter, Radiopaque TenckhoffFJS · Traditional | 02/27/1979SE |
| K781755 | Dap-PakKDJ · Traditional | 02/15/1979SE |
Questions and answers
When was Peritoneal Dialysis Cycler Set (8UNIT) cleared by the FDA?
Peritoneal Dialysis Cycler Set (8UNIT) (K812772) received a 510(k) decision of Substantially Equivalent on October 19, 1981, 14 days after the submission was received.
What is the product code of K812772?
The FDA product code is KDJ – Set, Administration, For Peritoneal Dialysis, Disposable, a Class II (moderate risk) device regulated under 21 CFR 876.5630.