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#
- 3006131984
- 3010626066
- 3020305857
- 3031841858
- 3031566471
- 3013521677
- 3038296449
- 3029833982
- 1419937
- 3011077581
- 2381321
- 3016693518
- 3015501220
- 3011800804
- 3029952735
- 3035371451
- 3020034975
- 3009247326
- 3038613158
- 3028172072
- 3012316249
- 3026986849
- 3043515178
- 3005031124
- 3029950834
- 3025360194
- 3010880718
- 3021544150
- 3006852457
- 3012684779
- 3018514222
- 3042823784
- 3016562061
- 1417592
- 3020119717
- 3010334650
- 3003927385
- 3010359222
- 1217805
- 3012119286
- 3030479957
- 3021376102
- 2435947
- 1423662
- 3009974348
- 3029923636
- 3027841329
- 3009124884
- 3012062596
- 3014759586
- 3008045828
- 3008711096
- 1721686
- 3007770329
- 3034993050
- 3012188053
- 3016871906
- 3021635975
- 3012298445
- 3016915446
- 3012605672
- 3002807523
- 3012759464
- 3007491602
- 3006446479
- 3013699454
- 3024790242
- 3040389677
- 3009243271
- 3009617411
- 3014166044
- 3008138005
- 3011139154
- 3003446042
- 3013561139
- 3021244152
- 3010337881
- 3003899230
- 3010205626
- 3015200642
Source Documents#
Other 510(k) Records For Product Code HGX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K260033 | Wearable Breast Pump (Model S21A) | Shenzhen TPH Technology Co., Ltd. | 2026-04-08 |
| K254258 | Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-04-08 |
| K253946 | Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-04-07 |
| K250208 | SPECTRA Wearable 2 | Uzinmedicare Co., Ltd. | 2026-04-06 |
| K252744 | Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) | Cixi Ruihong Electric Appliance Co., Ltd. | 2026-04-03 |
| K252583 | Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) | A Cute Baby, Inc. | 2026-03-12 |
| K253934 | Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-03-09 |
| K253149 | Motion InBra (YM-8801) wearable breast pump | Medela, LLC | 2026-02-13 |
Legacy Summary#
summary
FDA Review#
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