510(k) K161725
- Device
- Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double Pumping Tubing Kit, Retail, Connector Spare Parts Kit, Silicone Membrane, Retail, Power Adaptor, Retail
- Applicant
- MEDELA, INC
- 510(k) number
- K161725
- Product code
- HGX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-10-28
- Date received
- 2016-06-22
- Regulation
- 884.5160
- Classification name
- Pump, Breast, Powered
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT SOKOLOWSKI
- Address
- 1101 Corporate Dr. Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3002589861
- 3007770329
- 1424785
- 3026986849
- 3013561139
- 3016245319
- 2435947
- 3027841329
- 3009826814
- 3012316249
- 1423662
- 3043165985
- 3034993050
- 3008138005
- 3010626066
- 3035371451
- 3030978471
- 3003899230
- 1217805
- 3038613693
- 3014166044
- 3040389677
- 3027115730
- 3011800804
- 3000126629
- 1721686
- 3005031124
- 3003927385
- 3012759464
- 3031841858
- 3007491602
- 3012119286
- 3009974348
- 3003509351
- 3010337881
- 3017816623
- 3030671608
- 3029923636
- 2110540
- 3012298445
- 3039358595
- 3003446042
- 3016975995
- 3020034975
- 1419937
- 3008729914
- 3020994856
- 3016915446
- 3043515178
- 3006610790
- 3009617411
- 3010880718
- 3020305857
- 3021376102
- 3029952735
- 9710641
- 3011077581
- 3029833982
- 3002297831
- 3028172072
- 3025360194
- 3011191255
- 3027605322
- 3018514222
- 3012062596
- 3002807523
- 3012188053
- 3031566471
- 3038613158
- 3013521677
- 3021244152
- 3010334650
- 1417592
- 3011139154
- 3029950834
- 3006446479
- 3006774448
- 3006131984
- 3020119717
Source Documents#
Other 510(k) Records For Product Code HGX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261199 | Wearable Breast Pump (Model S32A) | Shenzhen TPH Technology Co., Ltd. | 2026-07-13 |
| K250070 | Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) | Shenzhen Changkun Technology Co., Ltd. | 2026-06-26 |
| K261025 | Wearable breast pump (QY-101, QY-102, QY-108) | Shenzhen Qinyi Electronic Technology Co., Ltd. | 2026-06-25 |
| K254254 | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-06-18 |
| K260538 | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-06-17 |
| K260346 | Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) | Polybell (Guangzhou) Limited | 2026-06-12 |
| K250129 | AViTA Breast Pump | Avita Corporation | 2026-06-11 |
| K260864 | Mother's Nature W1 Warming Wearable Breast Pump | Shenzhen TPH Technology Co., Ltd. | 2026-06-09 |
| K260956 | Spectra Platinum Mini | Uzinmedicare Co., Ltd. | 2026-06-04 |
| K254300 | eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009) | Anker Innovations Limited | 2026-05-29 |
| K254244 | Wearable Breast Pump (Model S39) | Shenzhen TPH Technology Co., Ltd. | 2026-05-21 |
| K254125 | Electric Breast Pump (HL-3058 II Pro) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 2026-05-13 |
| K253914 | Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-04-29 |
| K260239 | Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) | Jiangxi AOV Maternity & Baby Products Co., Ltd. | 2026-04-22 |
| K253510 | Freestyle Mini Hands-free | Medela, LLC | 2026-04-10 |
Legacy Summary#
summary
FDA Review#
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