DeviceClearance

Product code QFG— Clinical Chemistry

DEKA ACE Pump System

Classification name
Alternate Controller Enabled Insulin Infusion Pump
Device class
Class 2
Regulation
21 CFR 880.5730
Advisory panel
Clinical Chemistry
Total cleared
29
First cleared
Most recent

FDA classification definition

“An alternate controller enabled insulin infusion pump (ACE insulin pump) is a device intended for the infusion of insulin into a patient. The ACE insulin pump may include basal and bolus drug delivery at set or variable rates. ACE insulin pumps are designed to reliably and securely communicate with external devices, such as automated insulin dosing systems, to allow insulin delivery commands to be received, executed, and confirmed. ACE insulin pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of insulin delivery.”

— U.S. Food and Drug Administration, device classification record for product code QFG under 21 CFR 880.5730, via openFDA

Market context for product code QFG

FDA has cleared 29 devices under product code QFG between 2019 and 2026, filed by 9 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QFG

Adverse events under product code QFG

product code QFG
Death
228
Injury
118,915
Malfunction
1,001,752
Other
7
Total
1,120,902

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 →

Recent clearances under product code QFG

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