Terumo Venoject Luer Adapter
FDA 510(k)Class II (US FDA 510(k))
by Terumo Corp.
Identifiers
- 510(k) Number
- K983490 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 device is a Luer adapter designed to transform standard infusion sets into winged blood collection sets. It allows multiple draws into evacuated tubes and accepts standard tube holders.
It is supplied sterile and disposable for single use. The adapter is made of latex-free materials and is intended for use in clinical and facility environments. Authorization is based on FDA 510(k) clearance under product code JKA, with K-number K983490.
Frequently asked questions
What is the TERUMO VENOJECT Luer Adapter used for?
The TERUMO VENOJECT Luer Adapter is designed to transform standard infusion sets into winged blood collection sets, enabling multiple blood draws into evacuated tubes using standard tube holders. This allows clinicians to use existing infusion setups for venipuncture without needing dedicated winged sets.
Is the TERUMO VENOJECT Luer Adapter sterile and intended for single use?
Yes, the device is supplied sterile and disposable for single use only. It is made of latex-free materials and must be discarded after one procedure to prevent cross-contamination and ensure patient safety in clinical and facility environments.
What regulatory authorization does the TERUMO VENOJECT Luer Adapter have?
The TERUMO VENOJECT Luer Adapter received FDA 510(k) clearance under product code JKA with K-number K983490. The clearance was granted as substantially equivalent to a predicate device, based on a traditional review process completed on November 30, 1998.
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: VENOJECT® Multi-Sample Luer Adapter - terumotmp.com, Terumo™ VENOJECT™ II Evacuated Tube Holder Luer Adapter, Terumo Medical Multisample VENOJECT Multi-Sample Luer Adapter - TMOMN2 ..., Terumo Medical Multisample VENOJECT Multi-Sample Luer Adapter - TMOMN2 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K983490 | Class II | Active |
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Manufacturer
- Manufacturer
- Terumo Corp.
Sources (1)
- FDA 510(k) K983490 24 fields · synced Sep 24, 2026