FDA applicant
Merit Medical Systems, Inc.
FDA records 182 decisions for Merit Medical Systems, Inc. (South Jordan, UT) from 1988 to 2026: 181 510(k) clearances and 1 original PMA approval. Most are in product codes DQX (Wire, Guide, Catheter) and DYB (Introducer, Catheter). Since 2016 its 510(k)s took a median of 92 days from receipt to decision, against 92 for FDA’s reviews in the same codes and years. Its devices cite 166 predicates, 84 of them its own earlier devices. 191 recalls are linked to its devices, 4 Class I.
FDA’s records also spell it “Merit Medical Systems”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Merit Medical Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
6in 2025
2026 so far, outlined.
Recalls per year
4in 2026
Class I Class II/III not classified
Planning a device like Merit 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) ReportOther applicant names beginning “Merit”
FDA records each applicant name separately; these may or may not be the same firm.