BD Vacutainer Multiple Sample Luer Adapter
by Becton, Dickinson and Company
510(k) K243649
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK243649 | Date21 Mar 2025 | 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- Withdrawn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, 18 Sep 2026
The BD Vacutainer Multiple Sample Luer Adapter is a medical device classified as a Luer Adapter (Product Code: JKA). It is designed to facilitate the connection of multiple blood collection tubes to a single needle or catheter during venipuncture, enabling sequential sample collection without repeated needle insertion. This adapter ensures compatibility with BD Vacutainer blood collection systems, enhancing efficiency in phlebotomy procedures.
This device is intended for single-use in clinical settings, such as hospitals, laboratories, and outpatient care facilities. Supplied sterile and packaged individually, it requires no special storage conditions beyond protection from contamination. The adapter adheres to FDA 510(k) clearance (K243649) under the Clinical Chemistry advisory committee and is classified as substantially equivalent to a predicate device. Compatibility is limited to BD Vacutainer blood collection tubes and systems.
From the manufacturer
BD Vacutainer Plus Tubes are made of a special formulation of the plastic, polyethylene terephthalate (PET). This special formulation is extremely strong, dimensionally stable, and resistant to chemicals and breakage. What speed and time should the BD Vacutainer Blood Collection tubes be spun at?
BD is the inventor of BD Vacutainer® blood collection tubes as well as the worldwide leader in blood tubes. We support our products with extensive clinical expertise and educational materials to help you achieve the best possible results.
Other devices from Becton, Dickinson and Company
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the BD Vacutainer Multiple Sample Luer Adapter in a clinical setting?
The BD Vacutainer Multiple Sample Luer Adapter is designed to streamline blood collection by allowing multiple BD Vacutainer blood collection tubes to be attached to a single needle or catheter during venipuncture. This eliminates the need for repeated needle insertions, improving efficiency and patient comfort during sequential sample collection.
Is this adapter reusable, or is it intended for single-use only?
The adapter is explicitly intended for single-use only in clinical settings. This design ensures patient safety and sterility, as reuse could compromise the integrity of the device and introduce contamination risks.
How should the adapter be stored before use, and are there any special storage requirements?
The adapter is supplied sterile and packaged individually, so it only requires protection from contamination during storage. No special environmental conditions (like refrigeration or humidity control) are needed—standard clean, dry storage is sufficient.
Which blood collection tubes and systems is this adapter compatible with?
The adapter is limited to compatibility with BD Vacutainer blood collection tubes and systems only. It is not designed to work with non-BD brands or alternative phlebotomy devices, ensuring a secure and standardized connection.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?
The adapter received FDA 510(k) clearance (K243649) under the Clinical Chemistry advisory committee, with a determination of substantial equivalence to a predicate device. This means it was reviewed for safety and performance against an existing, legally marketed device and is authorized for use in clinical settings as described in its labeling.