FDA applicant
DreaMed Diabetes, Ltd.
FDA records 6 decisions for DreaMed Diabetes, Ltd. (Petah Tikva, IL) from 2018 to 2026: 5 510(k) clearances and 1 De Novo grant. Most are in product codes QCC (Insulin Pump Therapy Adjustment Calculator For…) and QRX (Continuous Glucose Monitor Informed Insulin…). Its devices cite 5 predicates, 4 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided DreaMed Diabetes, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like DreaMed Diabetes, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report