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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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.

Regulatory Consultant

Underwriters Laboratories, Inc.
JEFF D RONGERO

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 42
Devices cleared under the same product code (KZE) and FDA review panel - the closest regulatory comparables to K110456.
BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM
K121270 · Bioject Medical Technologies, Inc. · Jul 2012
PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI
K111517 · Pharmajet, Inc. · Jul 2011
LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA
K090959 · D'Antonio Consultants International, Inc. (Dci) · Dec 2009
ZETAJET
K090003 · Bioject, Inc. · Apr 2009
PHARMAJET NEEDLE-FREE INJECTION SYSTEM
K081532 · Pharmajet, Inc. · Feb 2009
AIRGENT, MODEL AG7000010
K082138 · Perfaction, Inc. · Jan 2009

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K110456 · PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM
Download PDF FDA Summary Pharmajet, Inc.