Cleared Special

K051985 - BIOVALVE MINI-JECT NEEDLEFREE INJECTOR

K051985 is an FDA 510(k) clearance for BIOVALVE MINI-JECT NEEDLEFREE INJECTOR, manufactured by Biovalve Technologies, Inc.. The device is a Class 2 General Hospital device with product code KZE cleared through the Special 510(k) pathway after a 26-day FDA review.

K051985 · Biovalve Technologies, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
26d
Days
Class 2
Risk

K051985 is an FDA 510(k) clearance for the BIOVALVE MINI-JECT NEEDLEFREE INJECTOR. Classified as Injector, Fluid, Non-electrically Powered (product code KZE), Class II - Special Controls.

Submitted by Biovalve Technologies, Inc. (Westborough, US). The FDA issued a Cleared decision on August 17, 2005 after a review of 26 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5430 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K051985

510(k) Number K051985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2005
Decision Date August 17, 2005
Days to Decision 26 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 129d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

KZE Device Classification - Class 2, Special Controls

Product Code KZE Injector, Fluid, Non-electrically Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5430
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - KZE Injector, Fluid, Non-electrically Powered

All 51
Devices cleared under the same product code (KZE) and FDA review panel - the closest regulatory comparables to K051985.
PHARMAJET NEEDLE-FREE INJECTION SYSTEM
K081532 · Pharmajet, Inc. · Feb 2009
AIRGENT, MODEL AG7000010
K082138 · Perfaction, Inc. · Jan 2009
COOL.CLICK 2
K060819 · Medical House Products Limited · Jun 2006
COOL.CLICK
K050734 · Bioject, Inc. · Jun 2005
GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000
K041239 · Genesis Medical Technology, Inc. · Nov 2004
HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500
K041280 · Felton International, Inc. · Jun 2004
K051985 · BIOVALVE MINI-JECT NEEDLEFREE INJECTOR
Download PDF FDA Summary Biovalve Technologies…