FDA.reportPublic FDA data

510(k) K233901

Device
Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)
Applicant
Shenzhen Desida Technology Co., Ltd.
510(k) number
K233901
Product code
BTA
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-20
Date received
2023-12-11
Regulation
878.4780
Classification name
Pump, Portable, Aspiration (Manual Or Powered)
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Shuangcheng Yuan
Address
5th Floor, Bldg. A, Sanmin Industrial Zone, Shilongzai, Shuitian Community, Shiyan St., Baoan District Shenzhen CN 518109 518109

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BTA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253629Momcozy Nasal Aspirator (BN007)Shenzhen Root Innovation Technology Co., Ltd.2026-05-26
K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)Shenzhen Root Innovation Technology Co., Ltd.2026-05-15
K260892Suction Pump (SU-90)Shenzhen HugeMed Medical Technical Development Co., Ltd.2026-05-14
K260473Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)Shenzhen Kingboom Technology Co., Ltd.2026-05-12
K253107Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)Shenzhen Dongjiang Technology Co., Ltd.2026-04-14
K260147Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)Shenzhen Kingboom Technology Co., Ltd.2026-03-13
K251450Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009)Shenzhen Desida Technology Co., Ltd.2025-06-06
K244033Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)Shenzhen Desida Technology Co., Ltd.2025-05-16
K251101AIRO Suction Unit (AIRO-01)Cro, LLC2025-04-26
K250697Electric Nasal Aspirator (BC026, BC025, BC023)Shenzhen Kingboom Technology Co., Ltd.2025-04-23
K241799ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS CAtmos Medizintechnik GmbH & Co. KG2025-03-07
K243138Geon (S2) Nasal AspiratorGeon Corporation2025-02-04
K241852Nasal Aspirator (NS 13)Avita Corporation2024-12-31
K242028Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)Dongguanshi Yiyingmei Technology Co., Ltd.2024-11-19
K241202Electric nasal aspirator (HTD2601US)Hetaida Technology Co., Ltd.2024-07-01