Cleared Traditional

K063348 - TOP FINE INSULIN SYRINGE

K063348 is an FDA 510(k) clearance for TOP FINE INSULIN SYRINGE, manufactured by Daejin Tech Medical Manufacturing Co., Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K063348 · 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
115d
Days
Class 2
Risk

K063348 is an FDA 510(k) clearance for the TOP FINE INSULIN SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Daejin Tech Medical Manufacturing Co., Ltd. (Deer Field, US). The FDA issued a Cleared decision on March 1, 2007 after a review of 115 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 - K063348

510(k) Number K063348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2006
Decision Date March 01, 2007
Days to Decision 115 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
14d faster than avg
Panel avg: 129d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 752
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K063348.
EVICEL APPLICATION DEVICE
K070575 · Omrix Biopharmaceuticals , Ltd. · May 2007
TEXIUM SYRINGE
K071108 · Cardinal Health, Alaris Products · May 2007
HASELMEIER PEN
K070100 · Haselmeier Sarl · Mar 2007
CAPTION APPLICATOR
K063535 · Smith & Nephew, Inc. · Feb 2007
FORSURE DISPOSABLE SYRINGE WITH NEEDLE, MODEL 1CC, 3C, 5CC, 10CC, 20CC, 50CC
K062753 · Surgimed, Inc. · Feb 2007
AUTO-FILL SYRINGE KIT, MODEL 7600
K063851 · Vascular Solutions, Inc. · Jan 2007
K063348 · TOP FINE INSULIN SYRINGE
Download PDF FDA Summary Daejin Tech Medical M…