Cleared Abbreviated

K020666 - DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K020666 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
115d
Days
Class 2
Risk

K020666 is an FDA 510(k) clearance for the DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Glendale, US). The FDA issued a Cleared decision on June 24, 2002 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K020666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2002
Decision Date June 24, 2002
Days to Decision 115 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 128d · This submission: 115d
Pathway characteristics
Standards-based clearance path.

Device Classification

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.

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