FDA applicant
Vyaire Medical, Inc.
FDA records 11 decisions for Vyaire Medical, Inc. (Mettawa, IL) from 2017 to 2024: 11 510(k) clearances. Most are in product codes DSA (Cable, Transducer And Electrode, Patient…) and BZC (Calculator, Pulmonary Function Data). Since 2016 its 510(k)s took a median of 221 days from receipt to decision, against 258 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Vyaire Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Vyaire Medical, Inc.’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 2017.
Planning a device like Vyaire Medical, 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