Cleared Traditional

K170982 - CADD- Solis Ambulatory Infusion Pump wi...

Also marketed or referenced as:
CADD®-Solis Infusion Pump, Model 2110 PharmGuard® Administrator Medication Safety Software CADD® Administration Sets Wireless Communication Module (CM)

K170982 is an FDA 510(k) clearance for CADD- Solis Ambulatory Infusion Pump wi..., manufactured by Smiths Medical Ads, Inc.. The device is a Class 2 General Hospital device with product code MEA cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K170982 · Smiths Medical Ads, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
143d
Days
Class 2
Risk

K170982 is an FDA 510(k) clearance for the CADD®- Solis Ambulatory Infusion Pump with Wireless Communication. Classified as Pump, Infusion, Pca (product code MEA), Class II - Special Controls.

Submitted by Smiths Medical Ads, Inc. (Plymouth, US). The FDA issued a Cleared decision on August 24, 2017 after a review of 143 days - within the typical 510(k) review window.

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 Ads, Inc. devices

FDA 510(k) Submission Details - K170982

510(k) Number K170982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2017
Decision Date August 24, 2017
Days to Decision 143 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
14d slower than avg
Panel avg: 129d · This submission: 143d
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 16
Devices cleared under the same product code (MEA) and FDA review panel - the closest regulatory comparables to K170982.
LifeCare PCA Infusion System
K143612 · Hospira, Inc. · Apr 2016
CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
K130394 · Smiths Medical Asd, Inc. · Dec 2013
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
K092313 · B.Braun Medical, Inc. · Nov 2009
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)
K051253 · Baxter Healthcare Corp · Jul 2005
HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07
K043256 · Hospira, Inc. · Dec 2004
LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K042800 · Hospira, Inc. · Oct 2004