510(k) K260134

Device: Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)
Applicant: Shenzhen Root Innovation Technology Co., Ltd.
510(k) number: K260134
Product code: BTA
Decision: Substantially Equivalent (SESE)
Decision date: 2026-05-15
Date received: 2026-01-16
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: N

Related Records

Applicant Contact

Contact: Haiyan Wen
Address: #2-201, Floor 2 Hasee Computer Bldg. # 2 Beier Rd., Bantian St., Longgang Shenzhen CN 518219 518219

FDA Registration Numbers

2024022
3005813597
3042507287
9610612
3010659128
3002807523
3017435705
3005527904
3007305485
3016591327
3011050570
3005146144
3010202439
2032112
3013857114
9680741
8010573
3015177409
3017520736
3009538961
3011816507
9610861
3004727197
9614434
2134752
9617787
1419937
3011716786
3004378299
1649660
9617543
3005168196
3003781173
3026986849
3009039068
9611174
2020550
3006142527
3014827316
3004050971
3038634684
1220908
3029871637
1450908
9680961
2022724
1060680
3016904853
3023876581
1043214
3016661562
3006174295
3004993040
3013095415
3010034780
3006617533
3013298431
3019924
1417592
1219343
3007360714
2523148
3003509351
1000604079
3008837339
1924066
3004145393
3014718111
3013556777
3021595514
3042156936
3014273557
3004464325
3015924074
2132111
1000122786
3031563234
3012322232
3005803793
3006789357

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code BTA

510(k)	Device	Applicant	Decision date
K260892	Suction Pump (SU-90)	Shenzhen HugeMed Medical Technical Development Co., Ltd.	2026-05-14
K260473	Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)	Shenzhen Kingboom Technology Co., Ltd.	2026-05-12
K253107	Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)	Shenzhen Dongjiang Technology Co., Ltd.	2026-04-14
K260147	Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)	Shenzhen Kingboom Technology Co., Ltd.	2026-03-13
K251450	Baby 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
K244033	Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)	Shenzhen Desida Technology Co., Ltd.	2025-05-16
K251101	AIRO Suction Unit (AIRO-01)	Cro, LLC	2025-04-26
K250697	Electric Nasal Aspirator (BC026, BC025, BC023)	Shenzhen Kingboom Technology Co., Ltd.	2025-04-23
K241799	ATMOS 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 C	Atmos Medizintechnik GmbH & Co. KG	2025-03-07
K243138	Geon (S2) Nasal Aspirator	Geon Corporation	2025-02-04
K241852	Nasal Aspirator (NS 13)	Avita Corporation	2024-12-31
K242028	Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)	Dongguanshi Yiyingmei Technology Co., Ltd.	2024-11-19
K241202	Electric nasal aspirator (HTD2601US)	Hetaida Technology Co., Ltd.	2024-07-01
K233901	Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)	Shenzhen Desida Technology Co., Ltd.	2024-03-20
K232831	Quiver Aspiration Pump	Anoxia Medical, Inc.	2024-02-22