← Back to catalogue

Electric Nasal Aspirator - DX85

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K253107

by Shenzhen Dongjiang Technology Co., Ltd.

Identifiers

510(k) Number
K253107 FDA 510(k)
FDA Product Code
BTA FDA 510(k)
Models / Variants
DT10 and DT50 FDA 510(k)EUDAMED
DX80 FDA 510(k)EUDAMED
DX85 FDA 510(k)EUDAMED
DX86 and DX90 FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4780 FDA 510(k)
Regulation Number
878.4780 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Electric Nasal Aspirator (DT10, DT50, DX80, DX85, DX86, DX90) is a portable, powered aspiration device designed for the removal of mucus from nasal passages. It operates as a suction-based system to clear obstructions, improving airflow and patient comfort, particularly for infants and young children with nasal congestion.

This device is supplied as a single-use or reusable unit, depending on model specifications, and is intended for use in home or clinical settings. Models vary by form factor—handheld with an air tube or integrated suction unit—and include different suction levels, sound outputs, and battery capacities. Authorized under FDA 510K and MDR compliance, it adheres to regulation 878.4780 and is classified as a Class II medical device. Sterility and MRI safety are not applicable as per the provided specifications.

Frequently asked questions

What are the key differences between the single-use and reusable models of this nasal aspirator?

The Electric Nasal Aspirator comes in both single-use and reusable models, depending on the variant. The single-use models (like the DT10 and DT50) are designed for one-time use, offering convenience for home settings or disposable use in clinical environments. In contrast, the reusable models (such as the DX80, DX85, DX86, and DX90) are built for repeated use, allowing for longer-term clinical or home use with proper cleaning and maintenance. The reusable models may also feature additional features like adjustable suction levels or longer battery life, depending on the specific variant.

How do I determine which model of the Electric Nasal Aspirator is best suited for my clinical or home use?

The choice depends on your needs: handheld models with an air tube (like the DT10 or DT50) are ideal for quick, single-use applications, such as in pediatric care or home settings. For more frequent or clinical use, the integrated suction units (DX80, DX85, DX86, DX90) offer durability, adjustable suction levels, and longer battery life. Consider factors like suction strength, battery capacity, and whether you prefer single-use convenience or reusable efficiency.

Are there any specific storage requirements for the Electric Nasal Aspirator?

The device should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Since the reusable models (DX80, DX85, DX86, DX90) require maintenance, ensure they are fully charged and stored with any accessories in a protective case if provided. Single-use models (DT10, DT50) do not require storage beyond their packaging until use, as they are intended for one-time application.

What regulatory pathways does this device follow, and how does that affect its use?

The Electric Nasal Aspirator is authorized under both FDA 510K and MDR (Medical Device Regulation) compliance, classified as a Class II device under regulation 878.4780. This means it has undergone rigorous review to ensure safety and effectiveness for its intended use—removing mucus from nasal passages. The regulatory clearance does not alter its clinical application but confirms it meets standards for use in both home and clinical settings, as long as it is used according to manufacturer instructions.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90), Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90), Electric Nasal Aspirator (DT10 and DT50, DX80, DX85… - FDA.report, K253107 - Electric Nasal Aspirator (DT10 and DT50 | FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Shenzhen Dongjiang Technology Co., Ltd.

Sources (2)

  • FDA 510(k) K253107 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026