Atlas FDA

BTA

159 FDA 510(k) clearances · Product code

76 daysmedian time to decision
241 days90th percentile
159clearances measured

FDA profile

Official device name
Pump, Portable, Aspiration (Manual Or Powered)
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4780
Medical specialty
General, Plastic Surgery
Flags
Third-party review eligible
Adverse events (MAUDE)
2014: 399 · 2015: 15 · 2016: 25 · 2018: 17 · 2019: 14 · 2026: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Momcozy Nasal Aspirator (BN007) (K253629)Shenzhen Root Innovation Technology Co., Ltd.2026-05-26
Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021) (K260134)Shenzhen Root Innovation Technology Co., Ltd.2026-05-15
Suction Pump (SU-90) (K260892)Shenzhen HugeMed Medical Technical Development Co., Ltd.2026-05-14
Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B) (K260473)Shenzhen Kingboom Technology Co., Ltd.2026-05-12
Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) (K253107)Shenzhen Dongjiang Technology Co., Ltd.2026-04-14
Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) (K260147)Shenzhen Kingboom Technology Co., Ltd.2026-03-13
Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009) (K251450)Shenzhen Desida Technology Co., Ltd.2025-06-06
Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610) (K244033)Shenzhen Desida Technology Co., Ltd.2025-05-16
AIRO Suction Unit (AIRO-01) (K251101)Cro, LLC2025-04-26
Electric Nasal Aspirator (BC026, BC025, BC023) (K250697)Shenzhen Kingboom Technology Co., Ltd.2025-04-23
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 (K241799)Atmos Medizintechnik GmbH & Co. KG2025-03-07
Geon (S2) Nasal Aspirator (K243138)Geon Corporation2025-02-04
Nasal Aspirator (NS 13) (K241852)Avita Corporation2024-12-31
Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) (K242028)Dongguanshi Yiyingmei Technology Co., Ltd.2024-11-19
Electric nasal aspirator (HTD2601US) (K241202)Hetaida Technology Co., Ltd.2024-07-01
Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009) (K233901)Shenzhen Desida Technology Co., Ltd.2024-03-20
Quiver Aspiration Pump (K232831)Anoxia Medical, Inc.2024-02-22
SOMAVAC® 100 Sustained Vacuum System (K231063)Somavac Medical Solutions, Inc.2023-05-12
Renova RP Centesis Pump (K221042)Gi Supply, Inc.2023-04-19
Enivo™ (K223373)Aroa Biosurgery , Ltd.2023-04-07
Geonic Nasal Aspirator, Geonic Nasal Cleaner (K220126)Geon Corporation2023-02-02
Electric nasal aspirator (K222547)Shenzhen Xinlianfeng Technology Co.,Ltd2022-10-20
SOMAVAC 100 Sustained Vacuum System (K222856)Somavac Medical Solutions, Inc.2022-10-19
Exsalta (K221676)Drw Medical2022-09-16
Medline Vacu-line Suction Aspirator (K203135)Medline Industries, Inc.2021-05-04
Cliq Aspirator (K201203)Anest Iwata Sparmax Co., Ltd.2020-09-03
FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator (K180863)Taidoc Technology Corporation2018-12-19
Thoraguard System (K181667)Centese, Inc.2018-11-29
SOMAVAC Device (K180606)Somavac Medical Solutions, Inc.2018-05-31
Rex Medical Aspiration Pump (K173389)Rex Medical, L.P.2018-01-30
Model 330 Multifunction Aspirator (K170533)ZOLL Medical Corporation2017-04-18
Aprima Smartesis Centesis Pump (K161002)Cook Incorporated2016-09-28
Vario 8/18/ci (K153663)Medela AG2016-05-18
TACVAC (K153459)Athena Gtx2016-01-28
SIMEX SUBGLOTTIC ASPIRATION SYSTEM (K141255)Simex Medizintechnik GmbH2014-09-22
MEDELA THOPAZ+ (K141553)Medela AG2014-08-25
EASY GO VAC (K140179)Precision Medical, Inc.2014-04-25
BASIC AND DOMINANT FLEX SUCTION PUMPS (K130123)Medela AG2013-10-11
MEDELA THOPAZ (K130210)Medela AG2013-03-15
EDRAIN CHEST DRAINAGE SYSTEM (K130131)Atrium Medical Corp.2013-02-28
EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET (K122619)Applied Medical2012-10-02
ATMOS E 201 THORAX AND ATMOS S 201 THORAX (K103042)Atmos, Inc.2011-04-15
AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES (K090379)Avita Corporation2010-05-26
V7 PORTABLE SUCTION UNITS (K093241)Hersill, S.L.2010-04-27
BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING (K092903)Maquet GmbH and Co. KG2009-12-01
ATMOS C361/C451 SUCTION PUMP (K090445)Atmos, Inc.2009-02-27
GENADYNE A4 POWERED SUCTION PUMP (K080745)Genadyne Biotechnologies, Inc.2008-07-30
MEDELA THOPAZ, MODEL 200 0288 (K080212)Medela AG2008-07-23
MOBLVAC W.C. (K081185)Ohio Medical Corporation2008-05-02
ASA01 HEAVY DUTY SUCTION PUMP (K071607)Zhongshan A&J Medical Equipment Co., Ltd.2007-06-26
SMARTSUCTION SOLO DEVICE (K062801)Haemonetics Corp.2006-10-04
CARE-E-VAC 3 (K062610)Ohio Medical Corporation2006-09-28
SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND DC30S (K061133)Novaspine, LLC2006-07-11
MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR (K061205)Medela AG2006-06-21
PIONEER U601 SERIES ASPIRATOR (K052650)Merits Health Products Co., Ltd.2005-11-04
SMARTSUCTION HARMONY DEVICE (K052626)Haemonetics Corp.2005-10-05
PENUMBRA ASPIRATION PUMP, MODEL 115V (K051758)Penumbra, Inc.2005-08-17
MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR (K043544)Medela AG2005-01-07
NOUVAG AG - VACUSON 40 AND VACUSON 60 (K042943)NOUVAG AG2004-12-17
ASPIRATION PUMP, MODEL IMD-020 (K041405)Industrial & Medical Design, Inc.2004-09-02
MEDI-PUMP ASPIRATOR, MODEL 1615 (K041199)Thomas Industries2004-06-01
S-SCORT...JR QUICKDRAW, MODEL 2400 (K041154)Sscor2004-05-18
SUPRAFLOW CONSOLE (K040239)Neomedix Corp.2004-02-17
MEDELA CLARIO HOME CARE PUMP (K033179)Medela AG2003-10-15
MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057 (K021368)Medela AG2002-05-15
MEDIPORT 2000 MOBILE (K013585)Servox Medizintechnik GmbH2002-01-28
DURQ/ QUALIDURA (K013116)Ever-Safety Technical Service2002-01-18
ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX (K011601)Ardo Medical AG2001-06-08
LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 (K993668)Laerdal Medical A/S1999-12-20
SORING GMBH, SONOCA 300 (K992026)Soring GmbH Medizintechnik1999-09-23
XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM (K984363)Xomed, Inc.1999-02-26
MEDCO ASPIRATOR IV (K982371)Medco Mfg.1999-02-12
BASIC, MEDIAN, DOMINANT, AND VARIO (K983552)Medela, Inc.1999-01-07
KSEA UNIMAT 45 (K981703)Karl Storz Endoscopy1998-08-12
DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR (K981602)Sunrise Medical Hhg, Inc.1998-07-17
EASYGO ASPIRATOR (K971749)Precision Medical, Inc.1998-04-01
IP-16 (K980301)Servizi Medico Estetici Italinai Srl.1998-03-24
LYSONIX ASPIRATION PUMP (K980454)Lysonix, Inc.1998-03-18
PSI-TEC ASPIRATOR (K980392)Byron Medical1998-03-05
MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM (K973268)Microaire Surgical Instruments, Inc.1997-11-26
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5 (K971107)Alexander Mfg. Co.1997-06-05
MODEL 8800 ASPIRATOR (K963775)Medical Specifics, Inc.1997-03-26
S-SCORT (2500) (K964997)Sscor1997-03-05
CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243) (K965059)Thomas Industries1997-03-04
GI SUPPLY PARACENTESIS PUMP (K970186)Gi Supply1997-02-14
SI CONTROLLER MODEL SI 500 (K960492)I.C Medical, Inc.1996-12-23
ACI SINGLE LUMEN BIOPSY NEEDLE (K954264)Advanced Cytometrix, Inc.1995-11-29
ACI FINE NEEDLE ASPIRATION BIOPSY KIT (K954287)Advanced Cytometrix, Inc.1995-11-29
ACI PULSATING VACUUM PUMP SYSTEM (K954286)Advanced Cytometrix, Inc.1995-11-29
MEDI PUMP ASPIRATOR MODELS 1130 AND 1135 (K952806)Thomas Industries1995-10-26
UIMAT PUMP (K953132)KARL STORZ Endoscopy-America, Inc.1995-08-23
MEDI - PUMP (K951729)Thomas Industries1995-08-21
AEROS ASPIRATOR (K952103)Aeros Instruments, Inc.1995-07-31
S-SCORT (K952632)Sscor1995-06-16
BIOPSY DEVICE ACCESSORY (K951326)Biopsys Medical, Inc.1995-05-15
SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000 (K950495)Surgical Dynamics, Inc.1995-05-09
AMBU PORTABLE SUCTION UNIT (K932031)Ambu, Inc.1995-05-05
ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT (K951423)Impact Instrumentation, Inc.1995-04-18
605 VACU-MAX (K941961)Medical Industries America, Inc.1995-03-02
MEDI-PUMP (K944399)Thomas Industries1995-01-18
Next →

Track BTA automatically

Every clearance here is in the API, with alerts when new ones post.