HGYClass I

Pump, Breast, Non-Powered

21 CFR 884.5150 / Obstetrics/Gynecology

HGY is the FDA product code for Pump, Breast, Non-Powered, a class I device type, regulated under 21 CFR 884.5150. As of 2026-09-10, FDA records hold 27 510(k) clearances under this code, the most recent dated 2010-11-05, and 2 recalls.

Classification record

Product code: HGY
Device name: Pump, Breast, Non-Powered
Regulation: 21 CFR 884.5150
Device class: Class I
Review panel: Obstetrics/Gynecology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 27
Ingested recalls: 2

Clearances, product code HGY

By decision year

27 clearances under product code HGY with a decision year between 1976 and 2010, 1983 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code HGY by decision year
Year	Clearances
1976	1
1981	2
1982	2
1983	5
1984	3
1985	3
1990	1
1993	1
1994	1
1995	2
1997	2
2001	2
2004	1
2010	1

Applicants with the most clearances

Product code HGY

Applicants holding the most 510(k) clearances under product code HGY
Applicant	Clearances
Medela AG	3
American Hospital Supply	2
Gerber Products Co.	2
Hollister, Inc.	2
Avent America, Inc.	1
Burditt & Calkins-Siemens-Elema	1
Crystal Medical Products, Inc.	1
D.J. Colgate Medical, Ltd.	1
Eklund & Co.	1
Evenflo Company, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 90 companies shown, in name order