510(k) Report

FDA applicant

Smash Ent., Inc.

Arden Hills, MN4 decisions1987–19880 recalls

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, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

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.

FIG. 1 — Smash Ent., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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