FDA applicant
Microaire Surgical Instruments, LLC
FDA records 16 decisions for Microaire Surgical Instruments, LLC (Charlottesville, VA) from 1996 to 2025: 16 510(k) clearances. Most are in product codes QPB (System, Suction, Lipoplasty For Removal) and HRX (Arthroscope). Since 2016 its 510(k)s took a median of 112 days from receipt to decision, against 153 for FDA’s reviews in the same codes and years. Its devices cite 21 predicates, 4 of them its own earlier devices. 4 recalls are linked to its devices.
FDA’s records also spell it “Microaire Surgical Instruments, Inc.”, “Microaire Surgical Instruments”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Microaire Surgical Instruments, LLC’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Microaire Surgical Instruments, 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) ReportOther applicant names beginning “Microaire”
FDA records each applicant name separately; these may or may not be the same firm.