FDA applicant
St Jude Medical
FDA records 139 decisions for St Jude Medical (Minnetonka, MN) from 1981 to 2018: 128 510(k) clearances and 11 original PMA approvals. Most are in product codes DYB (Introducer, Catheter) and DQK (Computer, Diagnostic, Programmable). Since 2016 its 510(k)s took a median of 256 days from receipt to decision, against 183 for FDA’s reviews in the same codes and years. Its devices cite 165 predicates, 85 of them its own earlier devices. 30 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “St. Jude Medical, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided St Jude Medical’s devices, and how often a recall has named them.
FDA decisions per year
3in 2018
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like St Jude Medical’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) Report