Pump in Style Advanced
Pump In Style Advanced is a powered breast pump for expressing and collecting milk, with single- or simultaneous double-breast pumping. A motor-driven diaphragm pump generates adjustable…
Pump In Style Advanced is a powered breast pump for expressing and collecting milk, with single- or simultaneous double-breast pumping. A motor-driven diaphragm pump generates adjustable vacuum.
The system has two programmed suction rhythms: a faster stimulation phase and a slower expression phase. A rotary control adjusts vacuum or cycling and switches the pump on or off.
Listed Item
Powered Double Breast Pump.
Controls and Power
A let-down control changes between the two phases. Power options include an AC adaptor, external AA-battery pack or vehicle adaptor. The pump is supplied nonsterile and is intended for one user in home or similar settings.
Who Else Makes It
Concentrated in Guangdong (28), Zhejiang (5), Hong Kong (2). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Essentia Industries Ltd. | Dong Guan | Guangdong | Contract manufacturer | 31 |
| Alleva Medical (D.G.) Ltd | Dongguan | Guangdong | Contract manufacturer | 13 |
| Joytech Healthcare Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 9 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Guangdong Xinbao Electrical Appliances Holdings Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 6 |
| Jiangsu Xinbei Electrical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 6 |
| Shenzhen Jingxintai Houseware Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Huizhou LVB Maternal AND Infant Supplies Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 3 |
| Huizhou Sunwinon Electronics Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 3 |
| Mastars Industries Co., Ltd. | Guangdong | Guangdong | Contract manufacturer | 3 |
| Rrdonnelley | Dongguan | Guangdong | Contract manufacturer | 3 |
| SFY Intelligent Technology (Suzhou) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 3 |
Showing 12 of 40. All 40 manufacturers in China registered for Pump, Breast, Powered
Record
| Listed by | Medela LLC, United States |
|---|---|
| FDA product code | HGX |
| Device type | Pump, Breast, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5160 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K181937 |
| Record published | 2019-06-03 |
| Record revised | 2024-09-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Carton, carton of 3 |
| Distribution end date | 2024-10-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PNSA Tote | In distribution | |
| Advanced Personal Double Starter Breast Pump | In distribution | |
| Pump In Style Advance Backpack | In distribution | |
| PNSA Tote | In distribution | |
| PNSA Metro Bag | In distribution | |
| PNSA Metro Bag | Withdrawn | |
| Advanced Personal Double Breast Pump | Withdrawn | |
| PNSA Tote | Withdrawn | |
| Pump In Style Advance Backpack | Withdrawn | |
| Advanced Personal Double Breast Pump | Withdrawn | |
| PNSA Starter Pump | Withdrawn | |
| PNSA Starter Pump | Withdrawn | |
| Pump In Style Advance backpack | Withdrawn | |
| Advanced Personal Double Breast Pump with Batt | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spectra | Uzinmedicare Co., Ltd. | 144 |
| Freemie | Dao Health | 93 |
| Ameda, Inc. | Ameda, Inc. | 72 |
| Motif Medical | Cimilre Co., Ltd. | 47 |
| Momcozy | Shenzhen Root Innovation Technology Co., Ltd. | 44 |
| Symmetrical Health, LLC | Cimilre Co., Ltd. | 28 |
| Electric Breast Pump | Ningbo Huiyoo Baby Products Co., Ltd. | 28 |
| Ameda® | Cimilre Co., Ltd. | 22 |
| LVB | Huizhou LVB Maternal & Infant Supplies Co., Ltd. | 17 |
| Vive | Vive Health LLC | 17 |
| ViveCare | Vive Health LLC | 16 |
| Stella Baby USA | Cimilre Co., Ltd. | 15 |
Showing 12 of 307. All products under Pump, Breast, Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253510 | 2026-04-10 |
| K253149 | 2026-02-13 |
| K253498 | 2026-01-22 |
| K251377 | 2025-09-18 |
| K232608 | 2024-04-12 |
| K210759 | 2021-08-11 |
| K200508 | 2020-06-15 |
| K191653 | 2019-10-17 |
| K181937 | 2018-10-16 |
| K161725 | 2016-10-28 |
| K151632 | 2015-11-05 |
| K150499 | 2015-04-21 |
| K053052 | 2006-05-02 |
| K031614 | 2003-06-06 |
| K020518 | 2002-03-07 |
| K950750 | 1995-10-16 |
| K901344 | 1990-08-06 |
| K875300 | 1988-04-06 |
| K801862 | 1980-10-23 |
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 | 2011-01-10 | Not classified | Vendor change control | The performance of the pumps may be compromised due to the potentiometer used on the circuit board. Affected pumps may not turn on, may turn off on its own, may reduce or lose suction during the pumping process, or may make a clicking nois | 11,154 units | 2012-05-21 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-08-06 | Not classified | Packaging | The product sterility may be compromised due to possible pinholes in the rigid tray of the package. | 2,030,390 kits | 2011-09-07 |
| 2010-08-06 | Not classified | Packaging | The product sterility may be compromised due to possible pinholes in the rigid tray of the package. | 1,293,304 kits | 2011-09-07 |
| 2010-08-06 | Not classified | Packaging | The product sterility may be compromised due to possible pinholes in the rigid tray of the package. | 581,296 kits | 2011-09-07 |
| 2010-08-06 | Not classified | Packaging | The product sterility may be compromised due to possible pinholes in the rigid tray of the package. | 3,019,835 kits | 2011-09-07 |
| 2010-03-15 | Not classified | Labeling Change Control | The non-sterile devices were erroneously packaged with instructions stating the devices are sterile and do not require cleaning before first use. | 13,834 kits | 2010-12-10 |
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.