Cleared Special

K022806 - DUOPRO SAFETY SYRINGE (DUOPROSS)

K022806 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 Special 510(k) pathway after a 27-day FDA review.

K022806 · 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
Sep 2002
Decision
27d
Days
Class 2
Risk

K022806 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 September 19, 2002 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K022806

510(k) Number K022806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2002
Decision Date September 19, 2002
Days to Decision 27 days
Submission Type Special
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
102d faster than avg
Panel avg: 129d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 K022806.
EXEL SECURETOUCH PTP SYRINGE
K011754 · Exelint Intl. Co. · Jan 2003
TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML)
K023458 · Taiject Medical Device Co., Ltd. · Nov 2002
1CC FUTURA SAFETY SYRINGE
K023323 · Futura Medical Technology · Oct 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
DUOPRO SAFETY SYRINGE (DUOPROSS)
K020623 · M.K. Meditech Co. , Ltd. · May 2002
K022806 · DUOPRO SAFETY SYRINGE (DUOPROSS)
Download PDF FDA Summary M.K. Meditech Co. , L…