Vacutainer Brand Luer Adapter
by Bd Becton Dickinson Vacutainer Systems Preanalytic 2 variants
510(k) K921520
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK921520 | Date10 Jul 1992 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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.
Other devices from Bd Becton Dickinson Vacutainer Systems Preanalytic
See all devices from Bd Becton Dickinson Vacutainer Systems Preanalytic →
Questions
AI-generated answers, 1 Oct 2026
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.