Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01

FDA 510(k) K043304 · Bioject Medical Technologies, Inc.

Substantially Equivalent

510(k) numberK043304

Submission

Device name
Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01
Applicant
Bioject Medical Technologies, Inc.
Bedminster, NJ, US
Received
November 30, 2004
Decision date
January 14, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LHI – Set, I.V. Fluid Transfer
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Specialty
General Hospital

Other 510(k)s with product code LHI

510(k)DeviceApplicantDecision
K252987ADRx™ Admixture DeviceLHI · Traditional Epic Medical Pte. , Ltd.06/12/2026SE
K260301Vial AdapterLHI · Traditional Hangzhou Qiantang Longyue Biotechnology Co., Ltd.06/05/2026SE
K250345Medline Bag DecanterLHI · Traditional Medline Industries, LP10/24/2025SE
K251715FlowArt® Vial Access Device VentedLHI · Traditional Asset Medikal10/14/2025SE
K251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II…LHI · Traditional Microtek Medical, LLC09/16/2025SE
K243404HyHub™ and HyHub™ Duo Vial Access DevicesLHI · Traditional Takeda Pharmaceuticals07/18/2025SE
K240761Arisure® Closed Male Luer with Spike Adapter (YM060)LHI · Traditional Yukon Medical, LLC03/21/2025SE
K243985Rio™ Drug Reconstitution Transfer DeviceLHI · Traditional Icu Medical, Inc.01/22/2025SE
K243486SmartSiteTM Vented Vial Access DeviceLHI · Traditional Yukon Medical, LLC12/06/2024SE
K241976nextaro® va, 15mm, 5µmLHI · Special Sfm Medical Devices GmbH09/06/2024SE

More from Sfm Medical Devices GmbH

510(k)DeviceDecision
K121270Bioject Needle-Free Injection Management SystemKZE · Traditional 07/19/2012SE
K041564Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01LHI · Traditional 07/16/2004SE

Questions and answers

When was Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01 cleared by the FDA?

Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01 (K043304) received a 510(k) decision of Substantially Equivalent on January 14, 2005, 45 days after the submission was received.

What is the product code of K043304?

The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.