Blood Tubing Sets
by Bd Becton Dickinson Vacutainer Systems Preanalytic 510(k)
Active
510(k) K760042
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK760042 | Date30 Aug 1976 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KOC
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5820
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
Blood Tubing Sets are accessories for blood circuit hemodialysis. They are used in the extracorporeal circuit to transport blood between the patient and the hemodialysis machine.
These devices are supplied non-sterile and are intended for single use. They are regulated as Class II medical devices under FDA 510(k) clearance K760042, with product code KOC and regulation number 876.5820.
Other devices from Bd Becton Dickinson Vacutainer Systems Preanalytic
See all devices from Bd Becton Dickinson Vacutainer Systems Preanalytic →
Questions
AI-generated answers, 24 Sep 2026
What is the intended use of Blood Tubing Sets?
Blood Tubing Sets are used in the extracorporeal circuit to transport blood between the patient and the hemodialysis machine during hemodialysis treatment.
Are Blood Tubing Sets supplied sterile or non-sterile?
Blood Tubing Sets are supplied non-sterile, as stated in the device description, and are intended for single use only.
What regulatory pathway was used for Blood Tubing Sets?
Blood Tubing Sets were cleared through the FDA 510(k) process under clearance number K760042, with a traditional clearance type and substantially equivalent decision.