FDA applicant
Monarch Medical Technologies, LLC
FDA records 6 decisions for Monarch Medical Technologies, LLC (Charlotte, NC) from 2014 to 2024: 6 510(k) clearances. All are in product code NDC (Calculator, Drug Dose). Since 2016 its 510(k)s took a median of 123 days from receipt to decision, against 57 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 4 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Monarch Medical Technologies”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Monarch Medical Technologies, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
1in 2019
Class I Class II/III not classified
Planning a device like Monarch Medical Technologies, 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) ReportOther applicant names beginning “Monarch”
FDA records each applicant name separately; these may or may not be the same firm.