DeviceClearance

CADD®- Solis Ambulatory Infusion Pump with Wireless Communication +4 more— 510(k) K170982

Substantially Equivalent

Smiths Medical Ads, Inc.

FDA 510(k) clearance K170982 for CADD®- Solis Ambulatory Infusion Pump with Wireless Communication +4 more, Substantially Equivalent on 2017-08-24. Applicant: Smiths Medical Ads, Inc.. Device class: 2.

Clearance details

Device name as filed
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)
Applicant
Smiths Medical Ads, Inc.
Product code
Code MEA
Device class
Class 2
Regulation
21 CFR 880.5725
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Plymouth, MN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MEA

product code MEA
Death
19
Malfunction
25,089
Total
25,108

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K170982

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170982.

Data sourced from openFDA. This site is unofficial and independent of the FDA.