FDA applicant
Bourns Medical Systems, Inc.
FDA records 9 decisions for Bourns Medical Systems, Inc. (Mchenry, IL) from 1978 to 1980: 9 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and CAF (Nebulizer (Direct Patient Interface)). 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 Bourns Medical Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Bourns Medical Systems, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Bourns Medical Systems, 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