510(k) K260346
- Device
- Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)
- Applicant
- Polybell (Guangzhou) Limited
- 510(k) number
- K260346
- Product code
- HGX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-12
- Date received
- 2026-02-03
- 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
- N
Applicant Contact#
- Contact
- Qingliang Xu
- Address
- # 50, W. St., Xihu Village, Renhe Town Baiyun District Guangzhou CN 510470 510470
FDA Registration Numbers#
- 3013513831
- 1417592
- 3016915446
- 3009974348
- 3013521677
- 3038613158
- 3010626066
- 3015501220
- 3007491602
- 3018159965
- 3031566471
- 3035371451
- 3016562061
- 3013684412
- 3011191255
- 3008711096
- 3030479957
- 3013561139
- 3012759464
- 3010334650
- 3020305857
- 2435947
- 3012684779
- 3002589861
- 3020994856
- 3017816623
- 3016975995
- 1424785
- 3009243271
- 3021376102
- 3034993050
- 3016871906
- 3005031124
- 3021635975
- 3006131984
- 3011077581
- 3020848550
- 3031841858
- 3020119717
- 3029923636
- 3038613693
- 3009826814
- 3027115730
- 3030671608
- 1419937
- 3012298445
- 3012119286
- 3006774448
- 3027841329
- 3011800804
- 3009700166
- 3030978471
- 3011139154
- 3002297831
- 3014166044
- 3039358595
- 3012188053
- 3020034975
- 3029952735
- 2110540
- 3003446042
- 3013053058
- 3006852457
- 3038296449
- 3025360194
- 3012062596
- 3012605672
- 1423662
- 3012316249
- 3009617411
- 3043515178
- 3010834934
- 3040389677
- 3024790242
- 3003509351
- 3009247326
- 3014759586
- 3010359222
- 3008138005
- 3009124884
Source Documents#
Other 510(k) Records For Product Code HGX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254203 | Wearable Breast Pump (Model S36) | Shenzhen TPH Technology Co., Ltd. | 2026-09-17 |
| K261622 | Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62) | Philips Consumer Lifestyle B.V. | 2026-09-03 |
| K262774 | Wearable breast pump (Model: XN/MD-2249BS, ZFHF) | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2026-09-01 |
| K260643 | Cimilre Dual Max | Cimilre Co., Ltd. | 2026-08-21 |
| K261298 | Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) | Guangdong Youmeng Electrical Technology Co., Ltd. | 2026-08-20 |
| K260259 | DiscreetDuo™ Flow Wearable Breast Pump (Model S3) | Shenzhen TPH Technology Co., Ltd. | 2026-07-24 |
| 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 |
| 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 |