FDA applicant
Smash Ent., Inc.
FDA records 4 decisions for Smash Ent., Inc. (Arden Hills, MN) from 1987 to 1988: 4 510(k) clearances. Most are in product codes GKF (Instrument, Hematocrit, Automated) and JGS (Electrode, Ion Specific, Sodium). 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 Smash Ent., Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Smash Ent., Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Smash Ent., 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