FDA applicant
Inspiron Corp.
FDA records 20 decisions for Inspiron Corp. (Mchenry, IL) from 1976 to 1986: 20 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and BTT (Humidifier, Respiratory Gas, (Direct Patient…). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Inspiron Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Inspiron Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Inspiron Corp.’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