FDA applicant
Surgical Theater, LLC
FDA records 8 decisions for Surgical Theater, LLC (Mayfield Village, OH) from 2013 to 2025: 8 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and SBF (Orthopedic Augmented Reality). Since 2016 its 510(k)s took a median of 105 days from receipt to decision, against 98 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 6 of them its own earlier devices. 7 recalls are linked to its devices.
FDA’s records also spell it “Surgical Theater, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Surgical Theater, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
7in 2025
Class I Class II/III not classified
Planning a device like Surgical Theater, LLC’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