Cleared Abbreviated

K071567 - AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE

K071567 is an FDA 510(k) clearance for AUTOSAFE-REFLEX SAFETY NEEDLE, manufactured by Autosafe-Refelx, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Abbreviated 510(k) pathway after a 99-day FDA review.

K071567 · Autosafe-Refelx, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
99d
Days
Class 2
Risk

K071567 is an FDA 510(k) clearance for the AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Autosafe-Refelx, Inc. (Alpharetta, US). The FDA issued a Cleared decision on September 14, 2007 after a review of 99 days - within the typical 510(k) review window.

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 - K071567

510(k) Number K071567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2007
Decision Date September 14, 2007
Days to Decision 99 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 129d · This submission: 99d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 Consultant

Kema Quality B.V.
J A VAN VUGT

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 - FMI Needle, Hypodermic, Single Lumen

All 635
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K071567.
GRIPPER MICRO NEEDLE
K072059 · Smiths Medical MD, Inc. · Nov 2007
VACU-MED BLOOD COLLECTION NEEDLES
K071947 · Shina Corp. · Oct 2007
ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
K071998 · Arrow Intl., Inc. · Sep 2007
GREINER VACUETTE QUICKSHIELD COMPLETE
K072320 · Greiner Bio-One North America, Inc. · Sep 2007
SC PROFI FINE PEN NEEDLE, MODELS
K070988 · Shinchang Medical Co., Ltd. · Aug 2007
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE
K071785 · Smiths Medical Asd, Inc. · Aug 2007

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.

K071567 · AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE
Download PDF Autosafe-Refelx, Inc.