FDA applicant
Biotronik, Inc.
FDA records 115 decisions for Biotronik, Inc. (Lake Oswego, OR) from 1984 to 2026: 104 510(k) clearances and 11 original PMA approvals. Most are in product codes DTB (Permanent Pacemaker Electrode) and DQY (Catheter, Percutaneous). Since 2016 its 510(k)s took a median of 59 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 111 predicates, 87 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Biotronik, GmbH & Co.”, “Biotronik AG”, “Biotronik GmbH & Co. KG”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Biotronik, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Biotronik, 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 “Biotronik”
FDA records each applicant name separately; these may or may not be the same firm.