Dominant Flex
The Dominant Flex is an AC-powered suction pump for removing fluids, tissue, gases or other material during surgery or bedside care. Its uses include aspiration during flexible endoscopy…
The Dominant Flex is an AC-powered suction pump for removing fluids, tissue, gases or other material during surgery or bedside care. Its uses include aspiration during flexible endoscopy and suction from wounds, airways or respiratory support systems in clinical settings.
A piston-and-cylinder mechanism creates suction, while a microcontroller adjusts motor speed. The operator can select airflow of 40, 50 or 60 liters per minute using front-panel touch sensors, and a separate knob regulates vacuum.
Listed Item
Powered suction pump 101046566
Controls and Fluid Protection
A gauge displays vacuum in the tubing, and indicator lights show pump status. A safety set containing a small jar, lid and float helps prevent overflow into the pump. Portable and rack versions are available, with trolley mounting for the rack version.
Who Else Makes It
Concentrated in Guangdong (11), Jiangsu (1), elsewhere (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Avita (Wujiang) Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 15 |
| Shenzhen BI-Rich Medical Devices Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Shenzhen Desida Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Zhongshan A&E Machinery Industry Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 25 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Laerdal Medical (Suzhou) Co., Ltd. | 215009 Suzhou Jiangsu Province | Repacker / relabeller | 12 | |
| Dikaku Industrial Co., Limited | Hong Kong | Hong Kong | Private-label distributor | 9 |
| Medcodes Healthcare (Shenzhen) Limited | Shenzhen | Guangdong | Manufacturer | 9 |
| Shenzhen Root Innovation Technology Co., Ltd. | Shenzhen | Guangdong | Specification developer | 8 |
| Hetaida Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 8 |
| Zhongshan A&J Medical Equipment Co., Ltd. | Guangdong | Guangdong | Manufacturer | 7 |
Showing 12 of 14. All 14 manufacturers in China registered for Pump, Portable, Aspiration (Manual Or Powered)
Record
| Listed by | Medela LLC, United States |
|---|---|
| FDA product code | BTA |
| Device type | Pump, Portable, Aspiration (Manual Or Powered) |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4780 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K130123 |
| Record published | 2024-05-31 |
| Record revised | 2025-04-03 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 101046566 | In distribution | |
| 101046567 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| R&D Batteries, Inc. | R & D Batteries, Inc. | 104 |
| Gomco | Allied Medical LLC | 62 |
| Pump, Portable, Aspiration (Manual Or Powered) | Söring GmbH | 23 |
| Silicone tubing | Medela LLC | 10 |
| Grownsy | Oak Tech LLC | 8 |
| Nasal aspirator | Shenzhen Dongjiang Technology Co., Ltd. | 8 |
| Thopaz | Medela LLC | 6 |
| Precision Medical Inc. | Precision Medical Technologies | 6 |
| Basen | Dongguan Yiyingmei Technology Co., Ltd. | 6 |
| V7 | Hersill SL | 6 |
| Care-E-VAC | Hersill SL | 6 |
| Sscor Quickdraw® | Sscor, Inc. | 5 |
Showing 12 of 216. All products under Pump, Portable, Aspiration (Manual Or Powered)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153663 | 2016-05-18 |
| K141553 | 2014-08-25 |
| K130123 | 2013-10-11 |
| K130210 | 2013-03-15 |
| K080212 | 2008-07-23 |
| K061205 | 2006-06-21 |
| K043544 | 2005-01-07 |
| K033179 | 2003-10-15 |
| K021368 | 2002-05-15 |
| K983552 | 1999-01-07 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medela LLC | 510(k) number | 2020-12-02 | Class II | Process control | Incorrect expiration date of “2023-07-24” on label of sterile tubing. Correct expiration date should be “2021-07-24”. | 6,244 units | 2024-06-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.