FDA lists powered breast pumps under product code HGX, Class II, with a 510(k) submission type. Match the exact pump and label to its device-specific record and do not rely on marketing terms alone.
FDA identifies breast pumps as medical devices. For a powered pump, the product classification database lists a product code, device class, regulation number, and submission type.
Powered breast pump classification
| FDA field | Entry |
|---|---|
| Device name | Pump, breast, powered |
| Product code | HGX |
| Device class | Class II |
| Regulation number | 21 CFR 884.5160 |
| Submission type | 510(k) |
The FDA’s HGX classification record supplies these category details. FDA also states that “hospital-grade pump” is not a recognized term with a consistent definition, so the label alone does not identify a device’s classification.
Check the exact pump
- Record the product name, manufacturer, model, and whether the device is powered or a manual pump.
- Search FDA’s 510(k) and product-classification databases for the exact manufacturer and model.
- Compare the device record with the product label and included pump system.
- Check whether a related accessory has a separate device record or product code.
- Read the decision and stated intended use in the exact record.
- Compare marketing labels with the manufacturer’s regulatory documents and FDA terminology.
The FDA’s breast pump device page describes the device category, and its buying and renting page explains the FDA’s use of the term “hospital-grade.” For another reproductive-health device record, see Natural Cycles FDA De Novo status. To check a specific home test, see how to check FDA status of a pregnancy test. Browse breast pumps.
This page describes product classification and regulatory terms. Speak with a doctor or lactation professional about health concerns or medical decisions.
Sources
Common questions
Are breast pumps regulated by FDA?
FDA identifies breast pumps as medical devices and maintains product-code classification records for them.
What FDA product code identifies a powered breast pump?
FDA's product classification database lists HGX for a powered breast pump.
Does FDA define the term hospital-grade pump?
FDA says it does not recognize that term as having a consistent definition.