FDA applicant
Aeroclean Technologies, Inc.
FDA records 2 decisions for Aeroclean Technologies, Inc. (Palm Beach Gardens, FL) in 2022: 2 510(k) clearances. All are in product code FRA (Purifier, Air, Ultraviolet, Medical). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Aeroclean Technologies, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Aeroclean Technologies, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Aeroclean Technologies, 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) Report