K253072 is an FDA 510(k) clearance for the Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D). This device is classified as a Pump, Breast, Powered (Class II - Special Controls, product code HGX).
Submitted by Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 23, 2025, 91 days after receiving the submission on September 23, 2025.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K253072 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2025 |
| Decision Date | December 23, 2025 |
| Days to Decision | 91 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 |