There are three common types of breast pumps found in the market worldwide.
- Manual Breast Pumps
- Battery-powered Breast Pumps
- Electric Breast Pumps

FDA 510k Requirements
1. | Classification Name |
Powered Breast Pump |
2. | Regulation No. |
884.5160 |
3. | Product Code |
HGX |
4. | Device Class |
2 |
5. | Submission Type |
510(k) |
6. | Predicate device with link | |
7. | Type of 510k |
Traditional |
8. |
Performance Tests Names |
2. Electromagnetic compatibility testing 3. Evaluation of vacuum performance and Backflow |
9. | Biocompatibility Tests |
1. Cytotoxicity 2. Irritation 3. Sensitization |
10. | Clinical Data |
Not Required |
11. | Remarks /
Additional requirements |
1. Software Validation- minor level of concern 2. Usability 5. Cleaning validation |