Cleared Abbreviated

K090117 - AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET

K090117 is an FDA 510(k) clearance for AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, manufactured by Autosafe-Reflex, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Abbreviated 510(k) pathway after a 251-day FDA review.

K090117 · Autosafe-Reflex, Inc. · General Hospital
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Sep 2009
Decision
251d
Days
Class 2
Risk

K090117 is an FDA 510(k) clearance for the AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER IN.... Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Autosafe-Reflex, Inc. (Alpharetta, US). The FDA issued a Cleared decision on September 29, 2009 after a review of 251 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K090117

510(k) Number K090117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2009
Decision Date September 29, 2009
Days to Decision 251 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 129d · This submission: 251d
Pathway characteristics
Standards-based clearance path.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 632
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K090117 · AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET
Download PDF Autosafe-Reflex, Inc.