Cleared Traditional

K994384 - CLICKER

K994384 is an FDA 510(k) clearance for CLICKER, 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 177-day FDA review.

K994384 · Bioject, Inc. · General Hospital
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Jun 2000
Decision
177d
Days
Class 2
Risk

K994384 is an FDA 510(k) clearance for the CLICKER. Classified as Injector, Fluid, Non-electrically Powered (product code KZE), Class II - Special Controls.

Submitted by Bioject, Inc. (Portland, US). The FDA issued a Cleared decision on June 22, 2000 after a review of 177 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.

View all Bioject, Inc. devices

FDA 510(k) Submission Details - K994384

510(k) Number K994384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1999
Decision Date June 22, 2000
Days to Decision 177 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
48d slower than avg
Panel avg: 129d · This submission: 177d
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 K994384.
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
MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM
K991294 · Medi-Ject Corp. · Apr 1999
J-TIP NEEDLESS INJECTOR
K980082 · National Medical Products, Inc. · Mar 1998
J-TIP INJECTOR
K973254 · National Medical Products, Inc. · Nov 1997