HGXClass II

Pump, Breast, Powered

21 CFR 884.5160 / Obstetrics/Gynecology

HGX is the FDA product code for Pump, Breast, Powered, a class II device type, regulated under 21 CFR 884.5160. As of 2026-09-10, FDA records hold 250 510(k) clearances under this code, the most recent dated 2026-08-21, and 8 recalls.

Classification record

Product code: HGX
Device name: Pump, Breast, Powered
Regulation: 21 CFR 884.5160
Device class: Class II
Review panel: Obstetrics/Gynecology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 253
Ingested recalls: 8

Clearances, product code HGX

By decision year

253 clearances under product code HGX with a decision year between 1980 and 2026, 2026 the highest year at 33.

Show the numbers

510(k) clearances under FDA product code HGX by decision year
Year	Clearances
1980	2
1981	2
1984	1
1985	7
1986	1
1987	1
1988	1
1989	2
1990	3
1993	1
1994	2
1995	5
1996	2
1997	7
1999	2
2001	1
2002	6
2003	4
2004	1
2005	5
2006	2
2007	1
2008	2
2009	4
2010	7
2011	2
2012	6
2013	4
2014	3
2015	9
2016	7
2017	8
2018	6
2019	7
2020	9
2021	12
2022	15
2023	15
2024	19
2025	26
2026	33

Applicants with the most clearances

Product code HGX

Applicants holding the most 510(k) clearances under product code HGX
Applicant	Clearances
Shenzhen TPH Technology Co., Ltd.	23
Medela AG	19
Uzinmedicare Co., Ltd.	12
Shenzhen Root Innovation Technology Co., Ltd.	11
Evenflo Company, Inc.	9
Ardo Medical AG	5
Guangdong Horigen Mother & Baby Products Co., Ltd.	5
Crystal Medical Products, Inc.	4
Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd	4
Hygeia II Medical Group, Inc.	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 113 companies shown, in name order