Cleared Traditional

K042500 - DUOPROSS SYRINGES

K042500 is an FDA 510(k) clearance for DUOPROSS SYRINGES, manufactured by Duopross Meditech Corporation. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K042500 · Duopross Meditech Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
161d
Days
Class 2
Risk

K042500 is an FDA 510(k) clearance for the DUOPROSS SYRINGES. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Duopross Meditech Corporation (Albuquerque, US). The FDA issued a Cleared decision on February 22, 2005 after a review of 161 days - an extended review 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: 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.

View all Duopross Meditech Corporation devices

FDA 510(k) Submission Details - K042500

510(k) Number K042500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2004
Decision Date February 22, 2005
Days to Decision 161 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 129d · This submission: 161d
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 420
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K042500.
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K052034 · Terumo Medical Corp. · Aug 2005
SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE
K051720 · Synthes (Usa) · Jul 2005
STRYKER DISCMONITOR
K050753 · Stryker Instruments · May 2005
1BD SOLOSHOT IX SYRINGE
K042934 · Becton, Dickinson & CO · Oct 2004
BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR
K033589 · Micromedics, Inc. · Oct 2004
MAGELLAN RATIO DISPENSER KIT
K041830 · Medtronic Perfusion Systems · Sep 2004