Cleared Traditional

K130394 - CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 (FDA 510(k) Clearance)

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

K130394 · Smiths Medical Asd, Inc. · General Hospital
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Dec 2013
Decision
297d
Days
Class 2
Risk

K130394 is an FDA 510(k) clearance for the CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0. Classified as Pump, Infusion, Pca (product code MEA), Class II - Special Controls.

Submitted by Smiths Medical Asd, Inc. (St. Paul, US). The FDA issued a Cleared decision on December 9, 2013 after a review of 297 days - an extended review 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: 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 Smiths Medical Asd, Inc. devices

Submission Details

510(k) Number K130394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2013
Decision Date December 09, 2013
Days to Decision 297 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
168d slower than avg
Panel avg: 129d · This submission: 297d
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.