Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)— 510(k) K260473
Substantially EquivalentShenzhen Kingboom Technology Co., Ltd.
FDA 510(k) clearance K260473 for Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B), Substantially Equivalent on 2026-05-12. Applicant: Shenzhen Kingboom Technology Co., Ltd.. Device class: 2.
Summary
Shenzhen Kingboom Technology's Electric nasal aspirator lists five models (BC027, BC030, BC033, BC035 and BC035B). It's filed under BTA, manual or powered portable aspiration pumps.
Class II, 21 CFR 878.4780. The Ear, Nose, Throat review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.
Kingboom filed from Shenzhen, China. The decision came 89 calendar days after receipt (February 12 to May 12, 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
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- K260134 — Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02 +1 more
- K260892 — Suction Pump (SU-90)
- K253107 — Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)
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.