FDA applicant
Terumo Corp.
FDA records 34 decisions for Terumo Corp. (Elkton, MD) from 1991 to 2026: 34 510(k) clearances. Most are in product codes DTZ (Oxygenator, Cardiopulmonary Bypass) and DQX (Wire, Guide, Catheter). Since 2016 its 510(k)s took a median of 196 days from receipt to decision, against 138 for FDA’s reviews in the same codes and years. Its devices cite 44 predicates, 9 of them its own earlier devices. 12 recalls are linked to its devices.
FDA’s records also spell it “Terumo Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Terumo Corp.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
12in 2012
Class I Class II/III not classified
Planning a device like Terumo 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.