FDA applicant
Imricor Medical Systems, Inc.
FDA records 3 decisions for Imricor Medical Systems, Inc. (Burnsville, MN) in 2026: 3 510(k) clearances. Most are in product codes DQK (Computer, Diagnostic, Programmable) and DRF (Catheter, Electrode Recording, Or Probe…). Its devices cite 4 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Imricor Medical Systems”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Imricor Medical Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2026.
Planning a device like Imricor Medical Systems, Inc.’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