Closed Disconnect System
FDA 510(k) K900106 · Delmed, Inc.
510(k) numberK900106
Submission
- Device name
- Closed Disconnect System
- Applicant
- Delmed, Inc.
New Brunswick, NJ, US - Received
- January 9, 1990
- Decision date
- July 16, 1990
- 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
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| 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 |
|---|---|---|
| K895650 | Enteral Pump Set W/Entera-Flo SpikeKNT · Traditional | 10/02/1990SE |
| K895329 | 600ML and 1200ML Enteral Bag Adm. Set for EnteraKNT · Traditional | 10/02/1990SE |
| K895142 | Enteral Pump Set with Enteral SpikeKNT · Traditional | 10/02/1990SE |
| K894506 | Entera-Flo Enteral Feeding PumpFRN · Traditional | 08/06/1990SE |
| K901478 | Delmed 80/2 Dialysis System W/Last Bag OptionFKX · Traditional | 07/27/1990SE |
| K901477 | Delmed 80/2 Dialysis System W/UltrafiltrationFKX · Traditional | 07/27/1990SE |
| K895933 | Enteral Pump Sets for Use with Ross Flexiflo-IiiKNT · Traditional | 05/02/1990SE |
| K895919 | Enteral Bag Admini. Sets for Use W/Flexiflo-IiiKNT · Traditional | 05/02/1990SE |
| K895696 | Enteral Pump Set W/Enteral Spike for Use W/Feed PuKNT · Traditional | 05/02/1990SE |
| K895330 | 600ML and 1200ML Enteral Bag Adm. Set for FrentaKNT · Traditional | 05/02/1990SE |
Questions and answers
When was Closed Disconnect System cleared by the FDA?
Closed Disconnect System (K900106) received a 510(k) decision of Substantially Equivalent on July 16, 1990, 188 days after the submission was received.
What is the product code of K900106?
The FDA product code is KDJ – Set, Administration, For Peritoneal Dialysis, Disposable, a Class II (moderate risk) device regulated under 21 CFR 876.5630.