K.E.P. Connector And Clip
by K.E.P., LLC 510(k)
Active
510(k) K042900
Overview
The K.E.P. Connector and Clip is a set for the administration of peritoneal dialysis. It consists of a right-angle barbed tubing connector, a wire frame, and a suction cup designed to secure the position of outlet tubing on non-porous surfaces to enable the flow of waste dialysate.
This device is supplied as an assembled unit and is intended for single-use. It has received FDA 510(k) clearance under regulation number 876.5630.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK042900 | Date5 Nov 2004 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KDJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5630
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the primary function of the K.E.P. Connector and Clip?
This device is designed for the administration of peritoneal dialysis. It uses a right-angle barbed tubing connector, a wire frame, and a suction cup to secure outlet tubing to non-porous surfaces, which facilitates the proper flow of waste dialysate.
Is this device intended for multiple uses?
No, the K.E.P. Connector and Clip is intended for single-use only. It is supplied as an assembled unit and should be disposed of after the procedure to ensure patient safety and maintain hygiene standards.
What is the regulatory status of this device?
The K.E.P. Connector and Clip has received FDA 510(k) clearance under regulation number 876.5630. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices within the gastroenterology and urology medical specialties.