Biovalve Mini-Ject Needlefree Injector

FDA 510(k) K051985 · Biovalve Technologies, Inc.

Substantially Equivalent

510(k) numberK051985

Submission

Device name
Biovalve Mini-Ject Needlefree Injector
Applicant
Biovalve Technologies, Inc.
Westborough, MA, US
Received
July 22, 2005
Decision date
August 17, 2005
Decision
Substantially Equivalent (SESE)
Type
Special 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

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K121270Bioject Needle-Free Injection Management SystemKZE · Traditional Bioject Medical Technologies, Inc.07/19/2012SE
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
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
K050971Biovalve Insulin Delivery Systems (Bids)LZG · Traditional 08/16/2005SE
K032976Biovalve Miniject Needle-Free Injection System, Model FG-01-001KZE · Traditional 04/16/2004SE

Questions and answers

When was Biovalve Mini-Ject Needlefree Injector cleared by the FDA?

Biovalve Mini-Ject Needlefree Injector (K051985) received a 510(k) decision of Substantially Equivalent on August 17, 2005, 26 days after the submission was received.

What is the product code of K051985?

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