FDA Product Code BTA: Pump, Portable, Aspiration (manual Or Powered)
Leading manufacturers include Medela AG, Egnell, Inc. and Aeros Instruments, Inc..
160
Total
160
Cleared
109d
Avg days
1979
Since
Growing category -
15 submissions in the last 2 years
vs 7 in the prior period
Consistent review times:
113d avg (recent)
FDA 510(k) Cleared Pump, Portable, Aspiration (manual Or Powered) Devices (Product Code BTA)
160 devices
Cleared
Oct 07, 2026
Nasal Aspirator (TLC-N02)
Zhongshan GL Electronics Co. , Ltd.
Ear, Nose, Throat
58d
Cleared
May 26, 2026
Momcozy Nasal Aspirator (BN007)
Shenzhen Root Innovation Technology Co., Ltd.
Ear, Nose, Throat
188d
Cleared
May 15, 2026
Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02
Shenzhen Root Innovation Technology Co., Ltd.
Ear, Nose, Throat
119d
Cleared
May 14, 2026
Suction Pump (SU-90)
Shenzhen HugeMed Medical Technical Development Co., Ltd.
General & Plastic Surgery
57d
Cleared
May 12, 2026
Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)
Shenzhen Kingboom Technology Co., Ltd.
Ear, Nose, Throat
89d
Cleared
Apr 14, 2026
Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)
Shenzhen Dongjiang Technology Co., Ltd.
Ear, Nose, Throat
202d
Cleared
Mar 13, 2026
Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)
Shenzhen Kingboom Technology Co., Ltd.
Ear, Nose, Throat
52d
Cleared
Jun 06, 2025
Baby Nasal Aspirator (BN002)
Shenzhen Desida Technology Co., Ltd.
Ear, Nose, Throat
28d
Cleared
May 16, 2025
Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)
Shenzhen Desida Technology Co., Ltd.
Ear, Nose, Throat
137d
Cleared
Apr 26, 2025
AIRO Suction Unit (AIRO-01)
Cro, LLC
General & Plastic Surgery
15d
Cleared
Apr 23, 2025
Electric Nasal Aspirator (BC026, BC025, BC023)
Shenzhen Kingboom Technology Co., Ltd.
Ear, Nose, Throat
47d
Cleared
Mar 07, 2025
ATMOS C 051 Thorax (317.0200.0)
Atmos Medizintechnik GmbH & Co. KG
General & Plastic Surgery
259d
Cleared
Feb 04, 2025
Geon (S2) Nasal Aspirator
Geon Corporation
Ear, Nose, Throat
127d
Cleared
Dec 31, 2024
Nasal Aspirator (NS 13)
Avita Corporation
Ear, Nose, Throat
187d
Cleared
Nov 19, 2024
Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)
Dongguanshi Yiyingmei Technology Co., Ltd.
Ear, Nose, Throat
131d
Cleared
Jul 01, 2024
Electric nasal aspirator (HTD2601US)
Hetaida Technology Co., Ltd.
Ear, Nose, Throat
62d
Cleared
Mar 20, 2024
Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)
Shenzhen Desida Technology Co., Ltd.
Ear, Nose, Throat
100d
Cleared
Feb 22, 2024
Quiver Aspiration Pump
Anoxia Medical, Inc.
General & Plastic Surgery
162d
Cleared
May 12, 2023
SOMAVAC® 100 Sustained Vacuum System
Somavac Medical Solutions, Inc.
General & Plastic Surgery
28d
Cleared
Apr 19, 2023
Renova RP Centesis Pump
Gi Supply, Inc.
General & Plastic Surgery
376d
Cleared
Apr 07, 2023
Enivo™
Aroa Biosurgery , Ltd.
General & Plastic Surgery
154d
Cleared
Feb 02, 2023
Geonic Nasal Aspirator, Geonic Nasal Cleaner
Geon Corporation
Ear, Nose, Throat
380d
Cleared
Oct 20, 2022
Electric nasal aspirator
Shenzhen Xinlianfeng Technology Co.,Ltd
Ear, Nose, Throat
58d
Cleared
Oct 19, 2022
SOMAVAC 100 Sustained Vacuum System
Somavac Medical Solutions, Inc.
General & Plastic Surgery
28d
About Product Code BTA - Regulatory Context
510(k) Submission Activity
160 total 510(k) submissions under product code BTA since 1979, with 160 receiving FDA clearance (average review time: 109 days).
Submission volume has increased in recent years - 15 submissions in the last 24 months compared to 7 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - BTA Product Code
FDA review times for BTA submissions have been consistent, averaging 113 days recently vs 109 days historically.
BTA devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →