Cleared Traditional

K020623 - DUOPRO SAFETY SYRINGE (DUOPROSS)

K020623 is an FDA 510(k) clearance for DUOPRO SAFETY SYRINGE (DUOPROSS), manufactured by M.K. Meditech Co. , Ltd.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K020623 · M.K. Meditech Co. , Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
65d
Days
Class 2
Risk

K020623 is an FDA 510(k) clearance for the DUOPRO SAFETY SYRINGE (DUOPROSS). Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by M.K. Meditech Co. , Ltd. (North Attleboro, US). The FDA issued a Cleared decision on May 2, 2002 after a review of 65 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K020623

510(k) Number K020623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2002
Decision Date May 02, 2002
Days to Decision 65 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
64d faster than avg
Panel avg: 129d · This submission: 65d
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 K020623.
DUOPRO SAFETY SYRINGE (DUOPROSS)
K022806 · M.K. Meditech Co. , Ltd. · Sep 2002
TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML)
K022278 · Taiject Medical Device Co., Ltd. · Sep 2002
SAFEPRO SAFETY SYRINGE
K022063 · Formosa Medical Devices, Inc. · Aug 2002
OVUS CAPLESS SAFETY NEEDLE
K013006 · Ovus Systems · Feb 2002
ULTRASAFE DENTAL INJECTION SYSTEM
K013801 · Safety Syringes, Inc. · Dec 2001
3CC NMT SAFETY SYRINGE
K010819 · New Medical Technology , Ltd. · Nov 2001
K020623 · DUOPRO SAFETY SYRINGE (DUOPROSS)
Download PDF FDA Summary M.K. Meditech Co. , L…