FDA applicant
Karl Storz SE & CO. KG
FDA records 34 decisions for Karl Storz SE & CO. KG (Tuttlingen, DE) from 2018 to 2026: 34 510(k) clearances. Most are in product codes OWN (Confocal Optical Imaging) and FGB (Ureteroscope And Accessories, Flexible/Rigid). Since 2016 its 510(k)s took a median of 193 days from receipt to decision, against 147 for FDA’s reviews in the same codes and years. Its devices cite 49 predicates, 7 of them its own earlier devices. 22 recalls are linked to its devices.
FDA’s records also spell it “KARL STORZ SE & CO. KG”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Karl Storz SE & CO. KG’s devices, and how often a recall has named them.
FDA decisions per year
7in 2025
2026 so far, outlined.
Recalls per year
22in 2024
Class I Class II/III not classified
Planning a device like Karl Storz SE & CO. KG’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 “Karl”
FDA records each applicant name separately; these may or may not be the same firm.