FDA applicant
Terumo Medical Corp.
FDA records 160 decisions for Terumo Medical Corp. (Elkton, MD) from 1980 to 2023: 157 510(k) clearances and 3 original PMA approvals. Most are in product codes DYB (Introducer, Catheter) and DQX (Wire, Guide, Catheter). Since 2016 its 510(k)s took a median of 85 days from receipt to decision, against 70 for FDA’s reviews in the same codes and years. Its devices cite 108 predicates, 66 of them its own earlier devices. 35 recalls are linked to its devices.
FDA’s records also spell it “Terumo Medical Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Terumo Medical Corp.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2023
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Terumo Medical Corp.’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 “Terumo”
FDA records each applicant name separately; these may or may not be the same firm.