510(k) Report

FDA applicant

Standard Engineering

3053 Haasrode, BE1 decision1994–19940 recalls

FDA records 1 decision for Standard Engineering (3053 Haasrode, BE) in 1994: 1 510(k) clearance. All are in product code JQW (Station, Pipetting And Diluting, For Clinical…). 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, clinical chemistry panel, where it files most

How often FDA has decided Standard Engineering’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Standard Engineering since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Standard Engineering’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

Other applicant names beginning “Standard”

FDA records each applicant name separately; these may or may not be the same firm.