FDA applicant
Disetronic Medical Systems
FDA records 29 decisions for Disetronic Medical Systems (Fort Myers, FL) from 1991 to 2010: 29 510(k) clearances. Most are in product codes LZG (Pump, Infusion, Insulin) and FRN (Pump, Infusion). Its devices cite 28 predicates, 17 of them its own earlier devices. 40 recalls are linked to its devices.
FDA’s records also spell it “Disetronic Medical Systems AG”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Disetronic Medical Systems’s devices, and how often a recall has named them.
FDA decisions per year
1in 2010
2026 so far, outlined.
Recalls per year
1in 2015
Class I Class II/III not classified
Planning a device like Disetronic Medical Systems’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