Concord, MA, US · 6 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QFG | Alternate Controller Enabled Insulin Infusion Pump | Class II | Clinical Chemistry | 4 | 2026-04-30 |
| QJI | — | — | — | 2 | 2023-09-22 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2026-03-12 | Class II | Ongoing | Z-1996-2026 | iLet Bionic Pancreas, REF: BB1001 | — | insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch t… |
| 2025-08-13 | Class II | Ongoing | Z-1809-2026 | iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software | — | it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include cer… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-04-30 | K253976 | iLet ACE Pump | QFG | Class II | Clinical Chemistry |
| 2025-09-29 | K252770 | iLet ACE Pump | QFG | Class II | Clinical Chemistry |
| 2023-09-22 | K232224 | iLet® Dosing Decision Software | QJI | — | — |
| 2023-06-21 | K231485 | iLet® ACE Pump | QFG | Class II | Clinical Chemistry |
| 2023-05-19 | K223846 | iLet® ACE Pump | QFG | Class II | Clinical Chemistry |
| 2023-05-19 | K220916 | iLet® Dosing Decision Software | QJI | — | — |