Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BTA — Predicate Candidate Screening
159 FDA 510(k) clearances under this product code; the 50 most recent screened below.
76 daysmedian FDA review time
241 days90th percentile
159clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253629 | Momcozy Nasal Aspirator (BN007) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-05-26 | 188 | 0 |
| K260134 | Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN00 | Shenzhen Root Innovation Technology Co., Ltd. | 2026-05-15 | 119 | 0 |
| K260892 | Suction Pump (SU-90) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2026-05-14 | 57 | 0 |
| K260473 | Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B | Shenzhen Kingboom Technology Co., Ltd. | 2026-05-12 | 89 | 0 |
| K253107 | Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 an | Shenzhen Dongjiang Technology Co., Ltd. | 2026-04-14 | 202 | 0 |
| K260147 | Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, | Shenzhen Kingboom Technology Co., Ltd. | 2026-03-13 | 52 | 0 |
| K251450 | Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); | Shenzhen Desida Technology Co., Ltd. | 2025-06-06 | 28 | 0 |
| K244033 | Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NA | Shenzhen Desida Technology Co., Ltd. | 2025-05-16 | 137 | 0 |
| K251101 | AIRO Suction Unit (AIRO-01) | Cro, LLC | 2025-04-26 | 15 | 0 |
| K250697 | Electric Nasal Aspirator (BC026, BC025, BC023) | Shenzhen Kingboom Technology Co., Ltd. | 2025-04-23 | 47 | 0 |
| K241799 | ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (3 | Atmos Medizintechnik GmbH & Co. KG | 2025-03-07 | 259 | 0 |
| K243138 | Geon (S2) Nasal Aspirator | Geon Corporation | 2025-02-04 | 127 | 0 |
| K241852 | Nasal Aspirator (NS 13) | Avita Corporation | 2024-12-31 | 187 | 0 |
| K242028 | Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC- | Dongguanshi Yiyingmei Technology Co., Ltd. | 2024-11-19 | 131 | 0 |
| K241202 | Electric nasal aspirator (HTD2601US) | Hetaida Technology Co., Ltd. | 2024-07-01 | 62 | 0 |
| K233901 | Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA0 | Shenzhen Desida Technology Co., Ltd. | 2024-03-20 | 100 | 0 |
| K232831 | Quiver Aspiration Pump | Anoxia Medical, Inc. | 2024-02-22 | 162 | 0 |
| K231063 | SOMAVAC® 100 Sustained Vacuum System | Somavac Medical Solutions, Inc. | 2023-05-12 | 28 | 0 |
| K221042 | Renova RP Centesis Pump | Gi Supply, Inc. | 2023-04-19 | 376 | 0 |
| K223373 | Enivo™ | Aroa Biosurgery , Ltd. | 2023-04-07 | 154 | 0 |
| K220126 | Geonic Nasal Aspirator, Geonic Nasal Cleaner | Geon Corporation | 2023-02-02 | 380 | 0 |
| K222547 | Electric nasal aspirator | Shenzhen Xinlianfeng Technology Co.,Ltd | 2022-10-20 | 58 | 0 |
| K222856 | SOMAVAC 100 Sustained Vacuum System | Somavac Medical Solutions, Inc. | 2022-10-19 | 28 | 0 |
| K221676 | Exsalta | Drw Medical | 2022-09-16 | 99 | 0 |
| K203135 | Medline Vacu-line Suction Aspirator | Medline Industries, Inc. | 2021-05-04 | 197 | 0 |
| K201203 | Cliq Aspirator | Anest Iwata Sparmax Co., Ltd. | 2020-09-03 | 122 | 0 |
| K180863 | FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Asp | Taidoc Technology Corporation | 2018-12-19 | 261 | 0 |
| K181667 | Thoraguard System | Centese, Inc. | 2018-11-29 | 157 | 0 |
| K180606 | SOMAVAC Device | Somavac Medical Solutions, Inc. | 2018-05-31 | 85 | 0 |
| K173389 | Rex Medical Aspiration Pump | Rex Medical, L.P. | 2018-01-30 | 92 | 0 |
| K170533 | Model 330 Multifunction Aspirator | ZOLL Medical Corporation | 2017-04-18 | 54 | 0 |
| K161002 | Aprima Smartesis Centesis Pump | Cook Incorporated | 2016-09-28 | 170 | 0 |
| K153663 | Vario 8/18/ci | Medela AG | 2016-05-18 | 149 | 0 |
| K153459 | TACVAC | Athena Gtx | 2016-01-28 | 58 | 0 |
| K141255 | SIMEX SUBGLOTTIC ASPIRATION SYSTEM | Simex Medizintechnik GmbH | 2014-09-22 | 131 | 0 |
| K141553 | MEDELA THOPAZ+ | Medela AG | 2014-08-25 | 75 | 0 |
| K140179 | EASY GO VAC | Precision Medical, Inc. | 2014-04-25 | 91 | 0 |
| K130123 | BASIC AND DOMINANT FLEX SUCTION PUMPS | Medela AG | 2013-10-11 | 267 | 0 |
| K130210 | MEDELA THOPAZ | Medela AG | 2013-03-15 | 45 | 0 |
| K130131 | EDRAIN CHEST DRAINAGE SYSTEM | Atrium Medical Corp. | 2013-02-28 | 41 | 0 |
| K122619 | EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET | Applied Medical | 2012-10-02 | 35 | 0 |
| K103042 | ATMOS E 201 THORAX AND ATMOS S 201 THORAX | Atmos, Inc. | 2011-04-15 | 183 | 0 |
| K090379 | AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES | Avita Corporation | 2010-05-26 | 463 | 0 |
| K093241 | V7 PORTABLE SUCTION UNITS | Hersill, S.L. | 2010-04-27 | 194 | 0 |
| K092903 | BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING | Maquet GmbH and Co. KG | 2009-12-01 | 71 | 0 |
| K090445 | ATMOS C361/C451 SUCTION PUMP | Atmos, Inc. | 2009-02-27 | 7 | 0 |
| K080745 | GENADYNE A4 POWERED SUCTION PUMP | Genadyne Biotechnologies, Inc. | 2008-07-30 | 135 | 0 |
| K080212 | MEDELA THOPAZ, MODEL 200 0288 | Medela AG | 2008-07-23 | 176 | 0 |
| K081185 | MOBLVAC W.C. | Ohio Medical Corporation | 2008-05-02 | 7 | 2 |
| K071607 | ASA01 HEAVY DUTY SUCTION PUMP | Zhongshan A&J Medical Equipment Co., Ltd. | 2007-06-26 | 14 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda