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Blood Tubing Sets

by Bd Becton Dickinson Vacutainer Systems Preanalytic 510(k)

Active United States

510(k) K760042

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK760042 Date30 Aug 1976ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.