Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)— 510(k) K260147
Substantially EquivalentShenzhen Kingboom Technology Co., Ltd.
FDA 510(k) clearance K260147 for Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036), Substantially Equivalent on 2026-03-13. Applicant: Shenzhen Kingboom Technology Co., Ltd.. Device class: 2.
Summary
Shenzhen Kingboom Technology's Electric nasal aspirator is filed under BTA, manual or powered portable aspiration pumps. The name lists six models: BC026, BC025, BC023, BC028, BC029 and BC036.
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 Kingboom Technology filed from Shenzhen, China. Review took 52 calendar days (January 20 to March 13, 2026).
Clearance details
- Applicant
- Shenzhen Kingboom 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)
More clearances from Shenzhen Kingboom Technology Co., Ltd.
view allAdverse 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.