DelClamp
by Delmed, Inc. 510(k)
Active
510(k) K893231
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK893231 | Date8 Jun 1989 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
Overview
AI-generated summary, 19 Sep 2026
The DelClamp is a Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), designed for use in peritoneal dialysis procedures. It functions as a clamping mechanism to control fluid flow within peritoneal dialysis circuits, ensuring precise regulation of dialysate infusion and drainage during treatment.
This device is supplied as a single-use, disposable item and is intended for use in clinical settings where peritoneal dialysis is administered. It is classified under FDA regulation 876.5630 and has received FDA 510(k) clearance (K893231) under the Traditional 510(k) review pathway, with a decision of Substantially Equivalent. Multiple registration numbers and FEI numbers (e.g., 3038277270, 3001239013) correspond to its administrative and tracking classifications.