Types of Breast Pumps
There are three common types of breast pumps found in the market worldwide.
- Manual Breast Pumps
- Battery-powered Breast Pumps
- Electric Breast Pumps
FDA Regulation on 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 / Abbreviated 510k) |
Traditional |
| 8. |
Performance Tests Names |
1. Electrical safety testing 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 3. Risk Management 4. Stability Studies 5. Cleaning validation |
