DeviceClearance

CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE— 510(k) K111275

Substantially Equivalent

Smiths Medical Asd, Inc.

FDA 510(k) clearance K111275 for CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE, Substantially Equivalent on 2013-02-01. Applicant: Smiths Medical Asd, Inc.. Device class: 2.

Clearance details

Applicant
Smiths Medical Asd, Inc.
Product code
Code FRN
Device class
Class 2
Regulation
21 CFR 880.5725
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
St. Paul, MN, US
Download summary PDFView on FDA.gov ↗

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More clearances from Smiths Medical Asd, Inc.

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Adverse events under product code FRN

product code FRN
Death
540
Injury
6,178
Malfunction
1,464,165
Other
52
Total
1,470,935

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 K111275

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 K111275.

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