FDA applicant
Aesculap, Inc.
FDA records 219 decisions for Aesculap, Inc. (Center Valley, PA) from 1991 to 2026: 219 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and JXG (Shunt, Central Nervous System And Components). Since 2016 its 510(k)s took a median of 154 days from receipt to decision, against 133 for FDA’s reviews in the same codes and years. Its devices cite 389 predicates, 154 of them its own earlier devices. 56 recalls are linked to its devices.
FDA’s records also spell it “Aesculap”, “Aesculap, Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Aesculap, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Aesculap, 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 “Aesculap”
FDA records each applicant name separately; these may or may not be the same firm.