Cleared Traditional

CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0

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

About This 510(k) Submission

K130394 is an FDA 510(k) clearance for the CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0, a Pump, Infusion, Pca (Class II — Special Controls, product code MEA), submitted by Smiths Medical Asd, Inc. (St. Paul, US). The FDA issued a Cleared decision on December 9, 2013, 297 days after receiving the submission on February 15, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K130394 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MEA — Pump, Infusion, Pca
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

Similar Devices — MEA Pump, Infusion, Pca

All 30
ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump
K162165 · Summit Medical Products, Inc. · Aug 2017
CADD?- Solis Ambulatory Infusion Pump with Wireless Communication; CADD?-Solis Infusion Pump, Model 2110; PharmGuard? Administrator Medication Safety Software; CADD? Administration Sets; Wireless Communication Module (CM)
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

More from Smiths Medical Asd, Inc.

View all
Hypodermic Needle-Pro? EDGE? Safety Device with Low Dead Space Syringe
K232943 · QNQ · May 2024
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula
K210833 · JOH · Nov 2021
Hypodermic Needle-Pro EDGE Safety Device
K211634 · FMI · Aug 2021
Intellifuse Administration and Intellifuse Blood Administration Sets
K192375 · FPA · Sep 2020
Level 1 Convective Warmer
K181699 · DWJ · Jul 2018