Submission Details
| 510(k) Number | K170982 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
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)
Aug 2017
Decision
143d
Days
Class 2
Risk
About This 510(k) Submission
K170982 is an FDA 510(k) clearance for the 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), a Pump, Infusion, Pca (Class II — Special Controls, product code MEA), submitted by Smiths Medical Ads, Inc. (Plymouth, US). The FDA issued a Cleared decision on August 24, 2017, 143 days after receiving the submission on April 3, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.
Device Classification
| Product Code | MEA — Pump, Infusion, Pca |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5725 |
Manufacturer
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