HGX · Pump, Breast, Powered · Chrysalis Intelligence

Device class

Class II

Regulation 884.5160

Total clearances

124

2020-01-16 → 2026-07-24

Last 12 months

Unique sponsors

Classification details

Medical specialty

Obstetrics/Gynecology

Review panel

Regulation number

884.5160

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Shenzhen TPH Technology Co., Ltd.	23	8	2026-07-24
Shenzhen Root Innovation Technology Co., Ltd.	10	8	2026-06-18
Medela, LLC	7	4	2026-04-10
Uzinmedicare Co.	7	4	2026-06-04
Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.	4	3	2026-05-13
Ningbo Youhe Electrical Appliance Technology Co., Ltd.	3	1	2025-10-22
Guangdong Youmeng Electrical Technology Co., Ltd.	3	2	2025-12-19
Guangdong Horigen Mother & Baby Products Co., Ltd.	3	0	2022-05-06
Imani Co.	3	0	2023-03-03
Hygeia II Medical Group, Inc.	3	0	2024-03-13
Huizhou Lvb Maternal and Infant Supplies Co., Ltd.	3	0	2025-08-13
Shenzhen Lutejiacheng Technology Co., Ltd.	3	0	2023-06-09
Philips Consumer Lifestyle - Innovation Site Eindhoven	2	0	2020-12-15
Ameda, Inc.	2	0	2022-10-12
Bistos Co., Ltd.	2	1	2025-09-25
Unimom.Co	2	0	2025-02-06
Shenzhen Changkun Technology Co., Ltd.	2	1	2026-06-26
A Cute Baby, Inc.	2	1	2026-03-12
Anker Innovations Limited	2	1	2026-05-29
Ardo Medical AG	2	0	2023-03-30
Milkmate Products, Inc.	2	0	2024-07-12
Jiangxi AOV Maternity & Baby Products Co., Ltd.	2	1	2026-04-22
Willow Innovations, Inc.	2	0	2023-10-16
Zhejiang Carebao Co., Ltd.	2	0	2023-01-13
Lansinoh Laboratories	2	0	2023-06-30

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
E0601	HCPCS	Continuous positive airway pressure (cpap) device ✓ CMS-verified description	High	HCPCS code specifically for continuous positive airway pressure (CPAP) but also breast pump electrical equipment
E0602	HCPCS	Breast pump, manual, any type ✓ CMS-verified description	High	HCPCS code for breast pump, electric, single or double

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-24	K260259	Shenzhen TPH Technology Co., Ltd.	DiscreetDuo Flow Wearable Breast Pump (Model S3)
2026-07-13	K261199	Shenzhen TPH Technology Co., Ltd.	Wearable Breast Pump (Model S32A)
2026-06-26	K250070	Shenzhen Changkun Technology Co., Ltd.	Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)
2026-06-25	K261025	Shenzhen Qinyi Electronic Technology Co., Ltd.	Wearable breast pump (QY-101, QY-102, QY-108)
2026-06-18	K254254	Shenzhen Root Innovation Technology Co., Ltd.	Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)
2026-06-17	K260538	Shenzhen Root Innovation Technology Co., Ltd.	Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )
2026-06-12	K260346	Polybell (Guangzhou) Limited	Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)
2026-06-11	K250129	Avita Corporation	AViTA Breast Pump
2026-06-09	K260864	Shenzhen TPH Technology Co., Ltd.	Mother's Nature W1 Warming Wearable Breast Pump
2026-06-04	K260956	Uzinmedicare Co., Ltd.	Spectra Platinum Mini
2026-05-29	K254300	Anker Innovations Limited	eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009)
2026-05-21	K254244	Shenzhen TPH Technology Co., Ltd.	Wearable Breast Pump (Model S39)
2026-05-13	K254125	Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.	Electric Breast Pump (HL-3058 II Pro)
2026-04-29	K253914	Shenzhen Root Innovation Technology Co., Ltd.	Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)
2026-04-22	K260239	Jiangxi AOV Maternity & Baby Products Co., Ltd.	Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)
2026-04-10	K253510	Medela, LLC	Freestyle Mini Hands-free
2026-04-08	K260033	Shenzhen TPH Technology Co., Ltd.	Wearable Breast Pump (Model S21A)
2026-04-08	K254258	Shenzhen Root Innovation Technology Co., Ltd.	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)
2026-04-07	K253946	Shenzhen Root Innovation Technology Co., Ltd.	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)
2026-04-06	K250208	Uzinmedicare Co., Ltd.	SPECTRA Wearable 2
2026-04-03	K252744	Cixi Ruihong Electric Appliance Co., Ltd.	Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)
2026-03-12	K252583	A Cute Baby, Inc.	Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)
2026-03-09	K253934	Shenzhen Root Innovation Technology Co., Ltd.	Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)
2026-02-13	K253149	Medela, LLC	Motion InBra (YM-8801) wearable breast pump
2026-02-13	K252422	Shenzhen TPH Technology Co., Ltd.	Wearable Breast Pump (Model W2)