BD Vacutainer Eclipse Blood Collection Needle
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K243207 FDA 510(k)
- FDA Product Code
- JKA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1675 FDA 510(k)
- Regulation Number
- 862.1675 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD Vacutainer Eclipse Blood Collection Needle is a safety-engineered, multi-sample blood collection needle designed for venipuncture procedures. It is classified under the Clinical Chemistry advisory committee category and is intended for collecting blood samples in clinical settings. The device incorporates a protective shield mechanism to mitigate needlestick injuries during use.
This needle is supplied sterile and intended for single-use. It is engineered for one-handed activation of the safety shield upon withdrawal from the vein, ensuring immediate needle protection. The device adheres to FDA 510K clearance under the Traditional pathway, with a K-number K243207 and product code JKA. Storage and handling must comply with standard sterile medical device protocols.
Frequently asked questions
How does the BD Vacutainer Eclipse Blood Collection Needle help prevent needlestick injuries during use?
The BD Vacutainer Eclipse Blood Collection Needle features a safety-engineered design with a protective shield that activates automatically upon withdrawal from the vein. This one-handed activation ensures immediate needle protection, significantly reducing the risk of needlestick injuries during or after venipuncture procedures.
Is the BD Vacutainer Eclipse Blood Collection Needle intended for reuse, or is it meant for single-use only?
The BD Vacutainer Eclipse Blood Collection Needle is explicitly designed for single-use only and is supplied sterile. Reusing this device could compromise sterility and patient safety, so adherence to single-use guidelines is essential.
What storage and handling precautions should be taken with the BD Vacutainer Eclipse Blood Collection Needle?
Since the device is sterile, it must be stored and handled according to standard sterile medical device protocols. This includes keeping it in its original packaging until use, protecting it from contamination, and ensuring it remains dry and free from physical damage to maintain sterility and functionality.
What types of blood collection procedures is this needle designed for, and how many samples can it collect?
The BD Vacutainer Eclipse Blood Collection Needle is designed for venipuncture procedures in clinical settings, specifically for collecting blood samples. While it is classified under the Clinical Chemistry advisory committee category, it is engineered as a multi-sample needle, allowing sequential blood draws into multiple evacuated tubes without reinsertion into the vein.
How do I know if this needle is compliant with FDA requirements, and what regulatory pathway was used for clearance?
This needle received FDA 510K clearance under the Traditional pathway, with a K-number of K243207 and product code JKA. The clearance was determined to be *Substantially Equivalent* (SESE) to a predicate device, ensuring it meets FDA standards for safety and effectiveness in blood collection applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BD Vacutainer® Eclipse™ blood collection needle | BD, BD Vacutainer® Eclipse™ blood collection needle | BD, BD Vacutainer™ Eclipse™ Blood Collection Needle
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243207 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K243207 24 fields · synced Sep 18, 2026