Cleared Traditional

K032976 - BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001

K032976 is an FDA 510(k) clearance for BIOVALVE MINIJECT NEEDLE-FREE INJECTION..., manufactured by Biovalve Technologies, Inc.. The device is a Class 2 General Hospital device with product code KZE cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K032976 · Biovalve Technologies, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
205d
Days
Class 2
Risk

K032976 is an FDA 510(k) clearance for the BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001. Classified as Injector, Fluid, Non-electrically Powered (product code KZE), Class II - Special Controls.

Submitted by Biovalve Technologies, Inc. (Worcester, US). The FDA issued a Cleared decision on April 16, 2004 after a review of 205 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5430 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K032976

510(k) Number K032976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2003
Decision Date April 16, 2004
Days to Decision 205 days
Submission Type Traditional
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
76d slower than avg
Panel avg: 129d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K032976.
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
AVANT GUARDIAN 101
K024018 · Avant Medical Corporation · Jan 2003
INJEX NEEDLE-FREE INJECTION SYSTEM
K020786 · Rosch AG Medizintechnic · Sep 2002
INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000
K022502 · Equidyne Systems, Inc. · Sep 2002
K032976 · BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001
Download PDF FDA Summary Biovalve Technologies…