Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)— 510(k) K253107
Substantially EquivalentShenzhen Dongjiang Technology Co., Ltd.
FDA 510(k) clearance K253107 for Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90), Substantially Equivalent on 2026-04-14. Applicant: Shenzhen Dongjiang Technology Co., Ltd.. Device class: 2.
Summary
Shenzhen Dongjiang Technology's Electric Nasal Aspirator is filed under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)). The name lists six models: DT10, DT50, DX80, DX85, DX86, and DX90.
Class II, 21 CFR 878.4780. The Ear, Nose, and Throat review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.
Shenzhen Dongjiang Technology filed from Shenzhen, China. The record shows 202 calendar days from receipt to decision (September 24, 2025 to April 14, 2026).
Clearance details
- Applicant
- Shenzhen Dongjiang Technology Co., Ltd.
- Product code
- Product code BTA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code BTA
view all- K262822 — Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401)
- K253629 — Momcozy Nasal Aspirator (BN007)
- K260134 — Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02 +1 more
- K260892 — Suction Pump (SU-90)
- K260473 — Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)
Adverse events under product code BTA
product code BTA- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.