FDA applicant
Kalajian Ent.
FDA records 3 decisions for Kalajian Ent. (Long Beach, CA) from 1987 to 1988: 3 510(k) clearances. Most are in product codes CBG (Spreader, Cuff) and BZA (Connector, Airway (Extension)). 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 Kalajian Ent.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Kalajian Ent. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Kalajian Ent.’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