Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail
FDA 510(k) K161725 · Medela, Inc.
510(k) numberK161725
Submission
- Device name
- Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail
- Applicant
- Medela, Inc.
Mchenry, IL, US - Received
- June 22, 2016
- Decision date
- October 28, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HGX – Pump, Breast, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5160
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HGX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261622 | Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52…HGX · Traditional | Philips Consumer Lifestyle B.V. | 09/03/2026SE |
| K262774 | Wearable breast pump (Model: XN/MD-2249BS, ZFHF)HGX · Traditional | Guangdong Horigen Mother & Baby Products Co., Ltd. | 09/01/2026SE |
| K260643 | Cimilre Dual MaxHGX · Traditional | Cimilre Co., Ltd. | 08/21/2026SE |
| K261298 | Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))HGX · Traditional | Guangdong Youmeng Electrical Technology Co., Ltd. | 08/20/2026SE |
| K260259 | DiscreetDuo Flow Wearable Breast Pump (Model S3)HGX · Traditional | Shenzhen TPH Technology Co., Ltd. | 07/24/2026SE |
| K261199 | Wearable Breast Pump (Model S32A)HGX · Traditional | Shenzhen TPH Technology Co., Ltd. | 07/13/2026SE |
| K250070 | Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)HGX · Traditional | Shenzhen Changkun Technology Co., Ltd. | 06/26/2026SE |
| K261025 | Wearable breast pump (QY-101, QY-102, QY-108)HGX · Traditional | Shenzhen Qinyi Electronic Technology Co., Ltd. | 06/25/2026SE |
| K254254 | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)HGX · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 06/18/2026SE |
| K260538 | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )HGX · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 06/17/2026SE |
More from Shenzhen Root Innovation Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253510 | Freestyle Mini Hands-freeHGX · Traditional | 04/10/2026SE |
| K253149 | Motion InBra (YM-8801) wearable breast pumpHGX · Traditional | 02/13/2026SE |
| K253498 | Pump In Style® Pro+HGX · Special | 01/22/2026SE |
| K251377 | Magic InBraHGX · Traditional | 09/18/2025SE |
| K232608 | Duo Hands-free Breast PumpHGX · Special | 04/12/2024SE |
| K223388 | Invia® Integrated DressingOMP · Traditional | 07/07/2023SE |
| K214112 | Invia Ease Negative Pressure Wound Therapy (NPWT) SystemOMP · Traditional | 07/26/2022SE |
| K210759 | Solo, Swing MaxiHGX · Traditional | 08/11/2021SE |
| K200508 | Pump In StyleHGX · Traditional | 06/15/2020SE |
| K191653 | Freestyle FlexHGX · Traditional | 10/17/2019SE |
Questions and answers
When was Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail cleared by the FDA?
Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail (K161725) received a 510(k) decision of Substantially Equivalent on October 28, 2016, 128 days after the submission was received.
What is the product code of K161725?
The FDA product code is HGX – Pump, Breast, Powered, a Class II (moderate risk) device regulated under 21 CFR 884.5160.