Tacvac
FDA 510(k) K153459 · Athena Gtx
510(k) numberK153459
Submission
- Device name
- Tacvac
- Applicant
- Athena Gtx
Johnson, IA, US - Received
- December 1, 2015
- Decision date
- January 28, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTA – Pump, Portable, Aspiration (Manual Or Powered)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code BTA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253629 | Momcozy Nasal Aspirator (BN007)BTA · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 05/26/2026SE |
| K260134 | Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A…BTA · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 05/15/2026SE |
| K260892 | Suction Pump (SU-90)BTA · Traditional | Shenzhen HugeMed Medical Technical Development… | 05/14/2026SE |
| K260473 | Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 05/12/2026SE |
| K253107 | Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)BTA · Traditional | Shenzhen Dongjiang Technology Co., Ltd. | 04/14/2026SE |
| K260147 | Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 03/13/2026SE |
| K251450 | Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator…BTA · Special | Shenzhen Desida Technology Co., Ltd. | 06/06/2025SE |
| K244033 | Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)BTA · Traditional | Shenzhen Desida Technology Co., Ltd. | 05/16/2025SE |
| K251101 | AIRO Suction Unit (AIRO-01)BTA · Traditional | Cro, LLC | 04/26/2025SE |
| K250697 | Electric Nasal Aspirator (BC026, BC025, BC023)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 04/23/2025SE |
More from Shenzhen Kingboom Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K233354 | WVSM Pro (Series) (500-0030-XX)MWI · Traditional | 06/26/2024SE |
| K191989 | WVSM (Wireless Vital Signs Monitor) RWC + miniCapMWI · Traditional | 01/29/2020SE |
| K173203 | Athena GTX Device Management Suite (ADMS) SoftwareMSX · Traditional | 03/14/2018SE |
| K160582 | WiCapDQA · Abbreviated | 09/02/2016SE |
| K130957 | WVSM (Wirless Vital Signs Monitor)MWI · Special | 04/30/2013SE |
| K113165 | Mini-MedicMWI · Traditional | 02/02/2012SE |
| K101674 | WVSM (Wireless Vital Signs Monitor), Model 5.0MWI · Traditional | 07/21/2010SE |
Questions and answers
When was Tacvac cleared by the FDA?
Tacvac (K153459) received a 510(k) decision of Substantially Equivalent on January 28, 2016, 58 days after the submission was received.
What is the product code of K153459?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.