FDA applicant
Bp, Ltd.
FDA records 3 decisions for Bp, Ltd. (Middletown, NY) in 1990: 3 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and BYG (Mask, Oxygen). 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 Bp, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Bp, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Bp, Ltd.’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