Bioject Needle-Free Injection Management System

FDA 510(k) K121270 · Bioject Medical Technologies, Inc.

Substantially Equivalent

510(k) numberK121270

Submission

Device name
Bioject Needle-Free Injection Management System
Applicant
Bioject Medical Technologies, Inc.
Tigard, OR, US
Received
April 26, 2012
Decision date
July 19, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KZE – Injector, Fluid, Non-Electrically Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5430
Specialty
General Hospital

Other 510(k)s with product code KZE

510(k)DeviceApplicantDecision
K111517Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01, Stratis Injector…KZE · Special Pharmajet, Inc.07/27/2011SE
K110456Pharmajet 0.1 ML Intradermal Needle-Free Injection SystemKZE · Traditional Pharmajet, Inc.03/02/2011SE
K090959Lectrajet Needle-Free Injection System, Model: M3 RaKZE · Traditional D'Antonio Consultants International, Inc. (Dci)12/24/2009SE
K090003ZetajetKZE · Abbreviated Bioject, Inc.04/02/2009SE
K081532Pharmajet Needle-Free Injection SystemKZE · Traditional Pharmajet, Inc.02/26/2009SE
K082138Airgent, Model AG7000010KZE · Traditional Perfaction, Inc.01/23/2009SE
K060819Cool.Click 2KZE · Traditional Medical House Products Limited06/16/2006SE
K051985Biovalve Mini-Ject Needlefree InjectorKZE · Special Biovalve Technologies, Inc.08/17/2005SE
K050734Cool.ClickKZE · Traditional Bioject, Inc.06/03/2005SE
K041239Genesis Medical Technologies, Inc. Pharmajet Needle-Free Injector, Model M2000KZE · Traditional Genesis Medical Technology, Inc.11/08/2004SE

More from Genesis Medical Technology, Inc.

510(k)DeviceDecision
K043304Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01LHI · Traditional 01/14/2005SE
K041564Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01LHI · Traditional 07/16/2004SE

Questions and answers

When was Bioject Needle-Free Injection Management System cleared by the FDA?

Bioject Needle-Free Injection Management System (K121270) received a 510(k) decision of Substantially Equivalent on July 19, 2012, 84 days after the submission was received.

What is the product code of K121270?

The FDA product code is KZE – Injector, Fluid, Non-Electrically Powered, a Class II (moderate risk) device regulated under 21 CFR 880.5430.