Cleared Traditional

K031909 - BETEC RETRACTABLE SAFETY SYRINGE (5ML)

K031909 is an FDA 510(k) clearance for BETEC RETRACTABLE SAFETY SYRINGE (5ML), manufactured by Betec Medical Science Co., Ltd.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K031909 · Betec Medical Science Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
109d
Days
Class 2
Risk

K031909 is an FDA 510(k) clearance for the BETEC RETRACTABLE SAFETY SYRINGE (5ML). Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Betec Medical Science Co., Ltd. (Flagstaff, US). The FDA issued a Cleared decision on October 7, 2003 after a review of 109 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 - K031909

510(k) Number K031909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2003
Decision Date October 07, 2003
Days to Decision 109 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
20d faster than avg
Panel avg: 129d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEG Device Classification - Class 2, Special Controls

Product Code MEG Syringe, Antistick
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 - MEG Syringe, Antistick

All 162
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K031909.
YUE PFONG SAFETY SYRINGE (3ML)
K040105 · Yue Pfong International Industrial Co., Ltd. · Apr 2004
INVIRO SNAP SAFETY INSULIN SYRINGE, 1 CC, MODEL 102905
K040036 · Inviro Medical · Mar 2004
10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE
K034031 · M.K. Meditech Co. , Ltd. · Jan 2004
U.S. TECHNOLOGIES, INC. RETRACTABLE SAFETY SYRINGE
K032247 · U.S. Technologies, Inc. · Sep 2003
INVIRO SNAP SAFETY SYRINGE, 1CC, 3CC, 5CC, AND 10CC
K032780 · Inviro Medical · Sep 2003
SAFEPRO PLUS SAFETY SYRINGE
K031830 · Formosa Medical Devices, Inc. · Aug 2003
K031909 · BETEC RETRACTABLE SAFETY SYRINGE (5ML)
Download PDF FDA Summary Betec Medical Science…