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Vacutainer Brand Luer Adapter

by Bd Becton Dickinson Vacutainer Systems Preanalytic 2 variants

510(k) K921520

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK921520 Date10 Jul 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JKA
Device Class
Class II
Regulation
21 CFR Part 862.1675
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Vacutainer Brand Luer Adapter is a Luer connector adapter (product code JKA) designed to facilitate secure, sterile connections between blood collection tubes and medical tubing, such as catheters or Foley ports. It provides a threaded Luer-Lok connection, eliminating the need for slip-style adapters and reducing the risk of disconnection during specimen sampling. This device is intended for use in phlebotomy and catheter-based procedures where reliable fluid transfer is critical.

Supplied sterile and intended for single-use, the Vacutainer Brand Luer Adapter is used in clinical settings such as hospitals, laboratories, and outpatient care facilities. It is compatible with standard Vacutainer blood collection systems and may be used for accessing blood or urine directly from indwelling catheters. The device is regulated under FDA 510(k) clearance (K921520) and falls under the Clinical Chemistry advisory committee classification. No MRI safety or reusable design information is specified.

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Questions

AI-generated answers, 1 Oct 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 Vacutainer Brand Luer Adapter used for?

    The Vacutainer Brand Luer Adapter is designed to create a secure, sterile connection between blood collection tubes and medical tubing, such as catheters or Foley ports. This threaded Luer-Lok connection ensures stable fluid transfer during phlebotomy or catheter-based procedures, minimizing the risk of accidental disconnections while sampling blood or urine. It is specifically intended for clinical settings like hospitals, labs, and outpatient care.

  • How is the Vacutainer Brand Luer Adapter supplied and prepared for use?

    The adapter is supplied sterile and packaged for single-use only. This ensures contamination-free connections when transferring fluids between collection tubes and catheters. Clinicians should follow standard sterile technique when attaching it to avoid compromising sterility before use.

  • Can the Vacutainer Brand Luer Adapter be reused?

    No, the Vacutainer Brand Luer Adapter is explicitly intended for single-use only. Reusing it could introduce contamination risks or compromise the integrity of the connection, potentially leading to fluid leaks or sample compromise during procedures.

  • What types of procedures or settings is this adapter compatible with?

    The adapter is compatible with standard Vacutainer blood collection systems and is suitable for procedures involving indwelling catheters, such as phlebotomy or urine sampling. It is commonly used in clinical environments like hospitals, laboratories, and outpatient care facilities where reliable fluid transfer is critical.

  • How does the Luer-Lok design improve safety compared to slip-style adapters?

    The Luer-Lok design threads tightly onto the connector, creating a secure, tamper-resistant fit that prevents accidental disconnections during fluid transfer. This reduces the risk of spills, contamination, or sample loss—critical factors in procedures where maintaining a sterile and uninterrupted connection is essential.