FDA applicant
Qrs Diagnostic, LLC
FDA records 7 decisions for Qrs Diagnostic, LLC (Plymouth, MN) from 1998 to 2009: 7 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and BZG (Spirometer, Diagnostic). Its devices cite 6 predicates, 1 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 Qrs Diagnostic, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2009
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Qrs Diagnostic, LLC’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