Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)

FDA 510(k) K260473 · Shenzhen Kingboom Technology Co., Ltd.

Substantially Equivalent

510(k) numberK260473

Submission

Device name
Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)
Applicant
Shenzhen Kingboom Technology Co., Ltd.
Shenzhen, CN
Received
February 12, 2026
Decision date
May 12, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BTA – Pump, Portable, Aspiration (Manual Or Powered)
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4780
Specialty
General, Plastic Surgery

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K253107Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)BTA · Traditional Shenzhen Dongjiang Technology Co., Ltd.04/14/2026SE
K260147Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)BTA · Traditional Shenzhen Kingboom Technology Co., Ltd.03/13/2026SE
K251450Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator…BTA · Special Shenzhen Desida Technology Co., Ltd.06/06/2025SE
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K250697Electric Nasal Aspirator (BC026, BC025, BC023)BTA · Traditional Shenzhen Kingboom Technology Co., Ltd.04/23/2025SE
K241799ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system…BTA · Traditional Atmos Medizintechnik GmbH & Co. KG03/07/2025SE

More from Atmos Medizintechnik GmbH & Co. KG

510(k)DeviceDecision
K260147Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)BTA · Traditional 03/13/2026SE
K250697Electric Nasal Aspirator (BC026, BC025, BC023)BTA · Traditional 04/23/2025SE

Questions and answers

When was Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B) cleared by the FDA?

Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B) (K260473) received a 510(k) decision of Substantially Equivalent on May 12, 2026, 89 days after the submission was received.

What is the product code of K260473?

The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.