Cleared Traditional

K013256 - BI-3M NEEDLE-FREE INJECTOR SYSTEM

K013256 is an FDA 510(k) clearance for BI-3M NEEDLE-FREE INJECTOR SYSTEM, manufactured by Felton International, Inc.. The device is a Class 2 General Hospital device with product code KZE cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K013256 · Felton International, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
67d
Days
Class 2
Risk

K013256 is an FDA 510(k) clearance for the BI-3M NEEDLE-FREE INJECTOR SYSTEM. Classified as Injector, Fluid, Non-electrically Powered (product code KZE), Class II - Special Controls.

Submitted by Felton International, Inc. (Lenexa, US). The FDA issued a Cleared decision on December 7, 2001 after a review of 67 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 - K013256

510(k) Number K013256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2001
Decision Date December 07, 2001
Days to Decision 67 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
62d faster than avg
Panel avg: 129d · This submission: 67d
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 51
Devices cleared under the same product code (KZE) and FDA review panel - the closest regulatory comparables to K013256.
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INJEX 30 NEEDLE FREE INJECTION SYSTEM
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JET SYRINGE MODEL-100500
K003741 · Equidyne Systems, Inc. · Jun 2001
SEROJET
K003908 · Bioject, Inc. · Mar 2001
INJEX 50 SYSTEM
K003864 · Equidyne Systems, Inc. · Mar 2001
K013256 · BI-3M NEEDLE-FREE INJECTOR SYSTEM
Download PDF FDA Summary Felton International,…