DeviceClearance

ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS— 510(k) K120872

Substantially Equivalent

Unomedical A/S Infusion Devices

FDA 510(k) clearance K120872 for ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS, Substantially Equivalent on 2012-04-20. Applicant: Unomedical A/S Infusion Devices. Device class: 2.

Clearance details

Applicant
Unomedical A/S Infusion Devices
Product code
Code FPA
Device class
Class 2
Regulation
21 CFR 880.5440
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Osted, DK
Download summary PDFView on FDA.gov ↗

Recent devices under product code FPA

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Adverse events under product code FPA

product code FPA
Death
95
Injury
14,421
Malfunction
125,815
Other
30
Total
140,361

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 K120872

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 K120872.

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