K241004 is an FDA 510(k) clearance for the Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2). This device is classified as a Pump, Breast, Powered (Class II - Special Controls, product code HGX).
Submitted by Huizhou Lvb Maternal and Infant Supplies Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on September 11, 2024, 152 days after receiving the submission on April 12, 2024.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K241004 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 2024 |
| Decision Date | September 11, 2024 |
| Days to Decision | 152 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HGX - Pump, Breast, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5160 |