DeviceClearance

Product code HGX— Obstetrics/Gynecology

Electric Breast Pump

Classification name
Pump, Breast, Powered
Device class
Class 2
Regulation
21 CFR 884.5160
Advisory panel
Obstetrics/Gynecology
Total cleared
252
First cleared
Most recent

Market context for product code HGX

FDA has cleared 252 devices under product code HGX between 1980 and 2026, filed by 110 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code HGX

Adverse events under product code HGX

product code HGX
Injury
758
Other
2
Total
760

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code HGX

1–100 of 252

Data sourced from openFDA. This site is unofficial and independent of the FDA.