Cleared Traditional

K130394 - CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0

K130394 is an FDA 510(k) clearance for CADD -SOLIS AMBULATORY INFUSION PUMP, manufactured by Smiths Medical Asd, Inc.. The device is a Class 2 General Hospital device with product code MEA cleared through the Traditional 510(k) pathway after a 297-day FDA review.

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

FDA 510(k) Submission Details - K130394

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
Combination Product No
PCCP Authorized No
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.

MEA Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MEA Pump, Infusion, Pca

All 20
Devices cleared under the same product code (MEA) and FDA review panel - the closest regulatory comparables to K130394.
CADD®- Solis Ambulatory Infusion Pump with Wireless Communication
K170982 · Smiths Medical Ads, Inc. · Aug 2017
LifeCare PCA Infusion System
K143612 · Hospira, Inc. · Apr 2016
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
K092313 · B.Braun Medical, Inc. · Nov 2009
CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR
K072144 · Smiths Medical MD, Inc. · Mar 2008
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)
K051253 · Baxter Healthcare Corp · Jul 2005
MEDLEY PCA MODULE, MODEL 8120
K043299 · Alaris Medical Systems, Inc. · Dec 2004