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SITCSection 8
U.S. imports of ozone, oxygen, aerosol & other therapeutic respiration apparatus (SITC 87233) totaled $370.1M in April 2026, traded with 47 countries.
Importers of Ozone, Oxygen, Aerosol & Other Therapeutic Respiration Apparatus paid $5.9M in duties in April 2026 — an effective duty rate of 9.8% on $59.7M in dutiable value, based on actual customs collections rather than the published tariff schedule.
Last updated: April 2026 dataOxygen concentrators, aerosol therapy nebulizers, artificial respiration ventilators, and ozone therapy units share this heading, making it one of the more heterogeneous groupings in the medical-device trade schedule. Ventilators and high-acuity respiratory devices are typically subject to FDA 510(k) clearance or premarket approval requirements, and importers must verify that foreign manufacturers hold the appropriate FDA establishment registration. Aerosol drug-delivery devices may additionally require coordination with FDA's Center for Drug Evaluation and Research if the device is co-packaged with a drug product. Supply-chain disruptions for critical respiratory equipment — highlighted during recent public-health emergencies — have made origin diversification and safety-stock planning a priority for hospital procurement teams.
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Yes. Ventilators and oxygen concentrators are Class II or Class III medical devices regulated by FDA's Center for Devices and Radiological Health. Imported units must originate from FDA-registered foreign establishments, and FDA may detain shipments for examination. Emergency Use Authorizations issued during public-health emergencies can temporarily modify these requirements, but importers should confirm current status with FDA or a licensed customs broker before each shipment.
Combination products — a device co-packaged or co-marketed with a drug — are assigned a primary mode of action by FDA's Office of Combination Products, which then designates the lead review center. The customs entry should reflect the correct HTS classification for the device component, but the importer must also satisfy any drug-import requirements for the pharmaceutical portion. Early engagement with FDA and a licensed customs broker is strongly recommended for combination-product shipments.
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Monthly import values over time