Cleared Special

K111517 - PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI

K111517 is an FDA 510(k) clearance for PHARMAJET STRATIS 0.5 ML NEEDLE-FREE IN..., manufactured by Pharmajet, Inc.. The device is a Class 2 General Hospital device with product code KZE cleared through the Special 510(k) pathway after a 55-day FDA review.

K111517 · Pharmajet, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
55d
Days
Class 2
Risk

K111517 is an FDA 510(k) clearance for the PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS I.... 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 July 27, 2011 after a review of 55 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K111517

510(k) Number K111517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2011
Decision Date July 27, 2011
Days to Decision 55 days
Submission Type Special
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
74d faster than avg
Panel avg: 129d · This submission: 55d
Pathway characteristics
Modification to existing cleared device.

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 42
Devices cleared under the same product code (KZE) and FDA review panel - the closest regulatory comparables to K111517.
BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM
K121270 · Bioject Medical Technologies, Inc. · Jul 2012
PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM
K110456 · Pharmajet, Inc. · Mar 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
K111517 · PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI
Download PDF FDA Summary Pharmajet, Inc.