QFG
28 FDA 510(k) clearances · Product code
98 daysmedian time to decision
469 days90th percentile
28clearances measured
FDA profile
- Official device name
- Alternate Controller Enabled Insulin Infusion Pump
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5730
- Medical specialty
- Clinical Chemistry
- FDA 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.
- Adverse events (MAUDE)
- 2021: 74,701 · 2022: 129,119 · 2023: 188,014 · 2024: 273,190 · 2025: 328,240 · 2026: 237,040
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Every clearance here is in the API, with alerts when new ones post.