Cleared Traditional

K110456 - PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM

K110456 is an FDA 510(k) clearance for PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FRE..., manufactured by Pharmajet, Inc.. The device is a Class 2 General Hospital device with product code KZE cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K110456 · Pharmajet, Inc. · General Hospital
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Mar 2011
Decision
14d
Days
Class 2
Risk

K110456 is an FDA 510(k) clearance for the PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM. Classified as Injector, Fluid, Non-electrically Powered (product code KZE), Class II - Special Controls.

Submitted by Pharmajet, Inc. (Golden, US). The FDA issued a Cleared decision on March 2, 2011 after a review of 14 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 Pharmajet, Inc. devices

FDA 510(k) Submission Details - K110456

510(k) Number K110456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2011
Decision Date March 02, 2011
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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.