Cleared Special

K041280 - HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500

K041280 is an FDA 510(k) clearance for HUMAN SUBCUTANEOUS INJECTOR, manufactured by Felton International, Inc.. The device is a Class 2 General Hospital device with product code KZE cleared through the Special 510(k) pathway after a 42-day FDA review.

K041280 · Felton International, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
42d
Days
Class 2
Risk

K041280 is an FDA 510(k) clearance for the HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500. Classified as Injector, Fluid, Non-electrically Powered (product code KZE), Class II - Special Controls.

Submitted by Felton International, Inc. (Lee'S Summit, US). The FDA issued a Cleared decision on June 24, 2004 after a review of 42 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 - K041280

510(k) Number K041280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2004
Decision Date June 24, 2004
Days to Decision 42 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
87d faster than avg
Panel avg: 129d · This submission: 42d
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 51
Devices cleared under the same product code (KZE) and FDA review panel - the closest regulatory comparables to K041280.
BIOVALVE MINI-JECT NEEDLEFREE INJECTOR
K051985 · Biovalve Technologies, Inc. · Aug 2005
COOL.CLICK
K050734 · Bioject, Inc. · Jun 2005
GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000
K041239 · Genesis Medical Technology, Inc. · Nov 2004
BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001
K032976 · Biovalve Technologies, Inc. · Apr 2004
AVANT GUARDIAN 101
K024018 · Avant Medical Corporation · Jan 2003
INJEX NEEDLE-FREE INJECTION SYSTEM
K020786 · Rosch AG Medizintechnic · Sep 2002
K041280 · HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500
Download PDF FDA Summary Felton International,…