FDA applicant
Terumo Cardiovascular Systems Corp.
FDA records 74 decisions for Terumo Cardiovascular Systems Corp. (Elkton, MD) from 2000 to 2024: 74 510(k) clearances. Most are in product codes DTZ (Oxygenator, Cardiopulmonary Bypass) and DWF (Catheter, Cannula And Tubing, Vascular…). Since 2016 its 510(k)s took a median of 175 days from receipt to decision, against 98 for FDA’s reviews in the same codes and years. Its devices cite 99 predicates, 42 of them its own earlier devices. 262 recalls are linked to its devices.
FDA’s records also spell it “Terumo Cardiovascular Systems Corporation”, “Terumo Cardiovascular Systems”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Terumo Cardiovascular Systems Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
2in 2025
Class I Class II/III not classified
Planning a device like Terumo Cardiovascular Systems 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.