Cleared Traditional

K050734 - COOL.CLICK

K050734 is an FDA 510(k) clearance for COOL.CLICK, manufactured by Bioject, Inc.. The device is a Class 2 General Hospital device with product code KZE cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K050734 · Bioject, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
74d
Days
Class 2
Risk

K050734 is an FDA 510(k) clearance for the COOL.CLICK. Classified as Injector, Fluid, Non-electrically Powered (product code KZE), Class II - Special Controls.

Submitted by Bioject, Inc. (Tualatin, US). The FDA issued a Cleared decision on June 3, 2005 after a review of 74 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bioject, Inc. devices

FDA 510(k) Submission Details - K050734

510(k) Number K050734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2005
Decision Date June 03, 2005
Days to Decision 74 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
55d faster than avg
Panel avg: 129d · This submission: 74d
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 20
Devices cleared under the same product code (KZE) and FDA review panel - the closest regulatory comparables to K050734.
AIRGENT, MODEL AG7000010
K082138 · Perfaction, Inc. · Jan 2009
COOL.CLICK 2
K060819 · Medical House Products Limited · Jun 2006
BIOVALVE MINI-JECT NEEDLEFREE INJECTOR
K051985 · Biovalve Technologies, Inc. · Aug 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
CLICKER
K994384 · Bioject, Inc. · Jun 2000