HS Code for Ventilators and Oxygen Equipment
The HS Code for ventilators and oxygen equipment is 901920. The MFN duty rate for importing to the US is Free.
| HS Code (6-digit) | 901920 |
|---|---|
| US Duty Rate (MFN) | Free |
| EU Duty Rate (MFN) | 0% |
| Chapter | 90 |
| Heading | 9019 |
| Last Updated | 2026-05 |
Description
Ozone therapy, oxygen therapy, aerosol therapy, artificial respiration apparatus
HS Code 901920 covers medical ventilators, oxygen therapy, and artificial respiration apparatus with a US duty rate of Free.
Frequently Asked Questions
What are the critical shipping and packaging requirements for ventilators and oxygen equipment under HTS 901920 to ensure they are not damaged in transit?
Ventilators and respiratory apparatus under HTS 901920 must be shipped in their original, manufacturer-sealed packaging with ample cushioning to protect sensitive electronic components and pressure gauges from shock. Carriers typically require these high-value medical devices to be shipped as cargo with insurance, and the outer packaging must be clearly marked 'Fragile - Medical Equipment' and kept upright to prevent internal damage.
What are the specific FDA and US Customs requirements for importing ventilators under HTS 901920 into the United States?
All ventilators and artificial respiration apparatus classified under HTS 901920 require pre-market approval or clearance from the U.S. Food and Drug Administration (FDA) as Class II or III medical devices. The importer of record must provide the FDA's 510(k) clearance or Pre-Market Approval (PMA) number to U.S. Customs and Border Protection (CBP) at entry, and the devices must be listed with an FDA-registered establishment.
Does the presence of a built-in ozone-generating module affect the classification of a medical ventilator under HTS 901920?
Yes, it can be significant. A primary function ozone generator would likely be excluded from 901920 and classified elsewhere, as this heading is specific to oxygen and aerosol therapy. However, a minor, ancillary ozone purification feature for the device's own air supply would generally not alter the classification.
Country-Specific Import Restrictions for Ventilators and Oxygen Equipment
For imports into the United States, ventilators classified under 9019.20.0000 are considered medical devices and require pre-market review and approval or clearance by the U.S. Food and Drug Administration (FDA). Shipments must comply with FDA regulations (21 CFR parts 801, 803, 807, 820, and 830) and generally require an FDA pre-market notification (510(k)) or pre-market approval (PMA). Additionally, imports may be subject to specific country-of-origin marking requirements and, for certain sensitive destinations, export controls under the U.S. Export Administration Regulations (EAR). It is critical to verify the latest FDA guidance and any applicable Temporary Enforcement Policies, which were common during the COVID-19 pandemic for emergency use authorizations (EUAs).
Common Classification Mistakes
A frequent error is classifying portable oxygen concentrators (POCs) for personal use under 9019.20, as they are often mistaken for therapeutic oxygen equipment. These devices are more correctly classified under HTS 9018.90 as 'other electro-medical apparatus.' Additionally, simple oxygen tanks, cylinders, or canisters without integrated valves, gauges, or regulators are not medical devices and are typically classified in Chapter 73 or 84 (e.g., 7311.00 for metal containers). Ensure the unit is a complete apparatus designed for medical respiratory therapy to use 9019.20.
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