Cleared Traditional

K063466 - TOP FINE

K063466 is an FDA 510(k) clearance for TOP FINE, manufactured by Daejin Tech Medical Manufacturing Co., Ltd.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K063466 · Daejin Tech Medical Manufacturing Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
106d
Days
Class 2
Risk

K063466 is an FDA 510(k) clearance for the TOP FINE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Daejin Tech Medical Manufacturing Co., Ltd. (Deer Field, US). The FDA issued a Cleared decision on March 2, 2007 after a review of 106 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K063466

510(k) Number K063466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2006
Decision Date March 02, 2007
Days to Decision 106 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
23d faster than avg
Panel avg: 129d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 686
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K063466.
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE
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LIFE LATCH SHARPS & BIOHAZARD CONTAINER
K071088 · M&M Industries, Inc. · Jul 2007
BD HYPOINT NEEDLE
K070440 · Becton, Dickinson & CO · Mar 2007
EZ-MIO STERNAL
K063567 · Vidacare Corporation · Jan 2007
PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110
K063450 · Smiths Medical Asd, Inc. · Jan 2007
BONE INJECTION GUN (B.I.G.)
K062940 · Waismed, Ltd. · Dec 2006
K063466 · TOP FINE
Download PDF FDA Summary Daejin Tech Medical M…