Oxygen Infusion Device
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π« Oxygen Infusion Device (Medical Oxygen Generators & Concentrators)
π HS Code Reference & Customs Clearance Guide | 2026 Latest Tariff Analysis | Professional Compliance Strategy
π I. Product Definition & Classification: Do You Truly Understand "Oxygen Infusion Devices"?
An "Oxygen Infusion Device" in international trade typically refers to Medical Oxygen Concentrators or Oxygen Generators. These are stationary or portable medical devices used to separate nitrogen from ambient air to provide high-purity oxygen for therapeutic use.
Key Distinction: * Medical Oxygen Concentrator (HS 9019.20): The primary machine that generates oxygen from air. This is the most common classification for "infusion" devices in a medical context. * Oxygen Cylinders/Concentrators (Empty or Full): If the device is simply a container without the concentration mechanism, it may fall under Chapter 73 (Iron/Steel) or Chapter 76 (Aluminum), but this is rare for "infusion" devices which imply active generation or delivery systems. * Parts and Accessories: Filters, humidifiers, nasal cannulas, and compressors are classified differently.
β οΈ Critical Classification Point:
- If the device generates oxygen from air using molecular sieves or membrane separation β 9019.20.00
- If the device is merely a delivery system (e.g., nebulizer, but not generating oxygen) β 9019.10 (Note: 9019.10 is for Mists and Inhalers, not oxygen generators. Use 9019.20 for oxygen therapy apparatuses).
- If it is a portable unit vs. stationary unit, the HS Code is generally the same, but declaration details differ.
π¦ II. HS Code Classification Details (2026 Latest Tariff Authority)
| HS Code | Product Description | Application Scenario | Includes Oxygen Generation? |
|---|---|---|---|
| 9019.20.00.00 | Mechanical therapy apparatuses; ozone therapy apparatuses; oxygen therapy apparatuses | Medical Oxygen Concentrators, Home Care Oxygen Generators, Hospital-Grade Units | β Yes (Primary Machine) |
| 9019.10.00.00 | Mists and inhalers | Nebulizers (for drugs, not oxygen generation) | β No |
| 8419.89.90.90 | Other machinery using heat/pressure (non-medical) | Industrial Oxygen Plants (Large Scale) | β Yes (But Industrial, not Medical) |
| 9018.90.00.00 | Other instruments/appliances for medical/surgical use | Accessories, Masks, Cannulas (if separate) | β No |
| 7323.93.00.00 | Table, kitchen or other household articles of iron/steel | Empty Steel Oxygen Tanks (Non-medical containers) | β No |
π Key Reminder:
- 9019.20.00.00 is the definitive code for Oxygen Therapy Apparatuses.
- Do not classify oxygen concentrators under "General Purpose Machinery" (84) or "Parts" (90) unless declared as such.
- If the device includes a battery for portability, it remains under 9019.20 (function determines classification, not power source).
π° III. 2026 Latest Tariff Rates Detail (Including Surtaxes & Policy Add-ons)
β Applicable Country: United States (US)
β Country of Origin: China (CN)
β Effective Date: From November 10, 2025 (for subsequent imports)
π― 1. 9019.20.00.00 ββ Oxygen Therapy Apparatuses (Medical Oxygen Concentrators)
| Item | Content |
|---|---|
| Base Tariff Rate | 0% (ad valorem) |
| USITC Surtax | +25% (Under USITC Footnote 9903.88.01) |
| IEEPA Surtax | +10% (For China/HK products, effective Nov 10, 2025) |
| Total Tariff Rate | 35% |
| Tax Calculation | CIF Value Γ 35% |
| De Minimis Exemption Eligible? | β No (deny_de_minimis) |
| Legal Authority Path | IEEPA:9903.01.25 β IEEPA:9903.01.24 β USITC:9019.20.00.00 β FOOTNOTE:9903.88.01 |
π Explanation:
- The 25% USITC surtax is part of Section 301 tariffs on specific Chinese imports.
- The 10% IEEPA surtax applies to all Chinese-origin goods imported into the US as of late 2025.
- Total 35% is a significant cost factor for medical devices from China.
- Note: Medical devices often face stricter regulatory scrutiny (FDA) in addition to tariffs.
π οΈ IV. Customs Clearance Practical Advice (Real-World Pitfall Avoidance)
β 1. Document Checklist (Non-negotiable)
| Document | Required | Explanation |
|---|---|---|
| β Product Specifications | βοΈ | Must state: Oxygen Purity (%), Flow Rate (L/min), Power Input, Noise Level. |
| β Medical Device Certificate | βοΈ | FDA 510(k) Clearance Number or CE Medical Device Registration. |
| β Technical Diagrams | βοΈ | Show internal components (molecular sieve, compressor, valve). |
| β Commercial Invoice | βοΈ | Explicitly state "Oxygen Therapy Apparatus, HS 9019.20.00.00". |
| β Certificate of Origin | βοΈ | To prove Chinese origin (and apply for tariff exemptions if applicable via specific exclusions). |
| β User Manual | βοΈ | Required for FDA compliance check at border. |
β 2. Declaration Strategy (Key Tips)
π₯ "Declare Function, Not Just Name"
| Scenario | Correct Declaration | Incorrect Approach |
|---|---|---|
| Oxygen Concentrator (Home Use) | 9019.20.00.00 - "Oxygen Therapy Apparatus" |
"Air Purifier" β Wrong Chapter, High Penalty |
| Oxygen Cylinder (Empty) | 7323.93.00.00 - "Empty Steel Tank" |
"Oxygen Infusion Device" β Misclassification |
| Nasal Cannula (Accessory) | 9018.90.00.00 - "Medical Accessories" |
"Part of Oxygen Machine" β May delay clearance |
| Portable Unit with Battery | 9019.20.00.00 |
Declare as "Portable Charger" β Rejection |
β 3. Special Circumstances Handling
| Situation | Handling Advice |
|---|---|
| OEM Branded Devices | Provide OEM contract + Brand Authorization Letter to prove ownership and avoid IP issues. |
| Used/Refurbished Devices | Prohibited for medical import into the US without strict FDA recertification. Declare as "New" only if true. |
| Dual-Use (Medical + Industrial) | If marketed as medical, must comply with FDA. If industrial, may fall under 8419.89. Choose carefully based on marketing. |
| Bundled with Oxygen Tanks | Declare separately. Machine: 9019.20. Tanks: 7323.93. Do not bundle into one line item unless they are a single kit with no alternative use. |
π V. Global Customs Clearance Comparison (2026 Latest)
| Country/Region | Recommended HS Code | Tariff (China Origin) | Certification Required | Notes |
|---|---|---|---|---|
| πΊπΈ USA | 9019.20.00.00 |
35% (25% USITC + 10% IEEPA) | FDA 510(k) + Labeling | High regulatory barrier |
| π¨π³ China | 9019.20.00.00 |
0% (Import Tariff) | NMPA License | No import tariff for medical devices |
| πͺπΊ EU | 9019.20.00.00 |
0% (if under CN) | CE MDR + IVDR | Strict post-market surveillance |
| π―π΅ Japan | 9019.20.00.00 |
0% | PMDA Approval | Mandatory safety standards |
| π¦πΊ Australia | 9019.20.00.00 |
5% | TGA Registration | No special surtax |
π Conclusion:
- USA is the most expensive market due to 35% combined tariffs.
- EU & Japan have low/no tariffs but high regulatory costs (CE/PMDA).
- China has no import tariff but requires NMPA approval for domestic sale.
π VI. Common Mistakes & Pitfall Guide (Lessons Learned)
β Mistake 1: Classifying as "Air Purifier" (HS 8421.39)
π Consequence: Misclassification. Customs may reclassify to 9019.20 and apply 35% tariff + penalties.
π Reality: Air purifiers remove dust; Oxygen concentrators separate gases. Different functions.
β Mistake 2: Declaring as "Machinery" (HS 8479)
π Consequence: Denied entry as a medical device. Requires FDA documentation.
π Reality: Must use 9019 for medical therapeutic apparatuses.
β Mistake 3: Ignoring FDA 510(k) Number in Invoice
π Consequence: Customs hold for regulatory check. Delay of 2-4 weeks.
π Reality: Always include FDA 510(k) number in the commercial invoice description.
β Mistake 4: Combining Accessories (Cannulas) with Main Unit
π Consequence: Incorrect valuation. Accessories have different tax treatment.
π Reality: Declare main unit and accessories separately if possible, or ensure the value is correctly apportioned.
β Correct Practice:
"Oxygen Therapy Apparatus, Medical Grade, 5L/min, Purity 93%, FDA 510(k) Cleared, Model XYZ, HS 9019.20.00.00"
π― VII. Conclusion: Precise Classification Saves Money & Time!
π― Remember the Mantra:
πΉ "Oxygen Generator = 9019.20, Not 8421 or 8479!"
πΉ "USA Tariff = 35%, Check FDA First!"
πΉ "Medical Device, High Value, High Compliance!"
π Pro Tip:
If your oxygen concentrator is originating from Vietnam or Thailand, you may be eligible for lower tariffs under USMCA or other FTAs, potentially reducing the 35% burden.
Recommendation: Apply for a Pre-Ruling from CBP before shipping to ensure correct HS Code and tariff application.
π£ Immediate Action Required:
π Consult a licensed customs broker + Provide FDA 510(k) Number + Verify Origin Certificate
π Ensure your Oxygen Infusion Devices clear customs smoothly, avoid 35% penalties, and reach patients on time!
β¨ Professional Customs Clearance Starts with Accurate Classification!
πΌ Every Percent of Tariff Matters in Medical Device Trade!
Customer Reviews
About HS Code Classification
The Harmonized System (HS) is an internationally standardized nomenclature developed by the World Customs Organization (WCO) to classify traded products. Over 200 countries use the HS system as the basis for customs tariffs, trade statistics, and import/export regulations.
Each HS code follows a hierarchical structure:
- Chapter (2 digits) β Broad category of goods (e.g., Chapter 84: Machinery and Mechanical Appliances)
- Heading (4 digits) β More specific grouping within the chapter
- Subheading (6 digits) β Internationally standardized breakdown, used by all WCO member countries
- National subdivisions (8-10 digits) β Country-specific extensions for further classification, such as US HTSUS 10-digit codes
Correct HS code classification is essential for smooth customs clearance, accurate duty payment, and compliance with trade regulations. Misclassification can lead to customs delays, overpayment of duties, or penalties.
When importing from CN to US, the applicable tariff rates may include:
- Most-Favored-Nation (MFN) rate β The standard duty rate applied to WTO members
- General rate β Applied to countries without trade agreements
- Trade remedy duties β Additional tariffs such as Section 301 (anti-dumping), Section 232 (national security), or countervailing duties
The information provided on this page is for reference purposes only. For official classification, please consult with your local customs authority or a licensed customs broker.