Cleared Traditional

K032233 - MEDLEY PCA MODULE, MODEL 8120 (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K032233 · Alaris Medical Systems, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Sep 2003
Decision
50d
Days
Class 2
Risk

K032233 is an FDA 510(k) clearance for the MEDLEY PCA MODULE, MODEL 8120. Classified as Pump, Infusion, Pca (product code MEA), Class II - Special Controls.

Submitted by Alaris Medical Systems, Inc. (San Diego, US). The FDA issued a Cleared decision on September 9, 2003 after a review of 50 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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.

View all Alaris Medical Systems, Inc. devices

Submission Details

510(k) Number K032233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2003
Decision Date September 09, 2003
Days to Decision 50 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
78d faster than avg
Panel avg: 128d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEA Pump, Infusion, Pca
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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.