510(k) Report

FDA applicant

Artec Environmental Monitoring Division

Noblesville, IN7 decisions1983–19900 recalls

FDA records 7 decisions for Artec Environmental Monitoring Division (Noblesville, IN) from 1983 to 1990: 7 510(k) clearances. Most are in product codes BTM (Ventilator, Emergency, Manual (Resuscitator)) and CAE (Airway, Oropharyngeal, Anesthesiology). 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, anesthesiology panel, where it files most

How often FDA has decided Artec Environmental Monitoring Division’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Artec Environmental Monitoring Division since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Artec Environmental Monitoring Division’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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