FDA applicant
Cerrozone, LLC
FDA records 2 decisions for Cerrozone, LLC (Maryland Heights, MO) from 2022 to 2024: 2 510(k) clearances. All are in product code FRF (Cleaner, Air, Medical Recirculating). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Cerrozone”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cerrozone, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Cerrozone, 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