K243508 is an FDA 510(k) clearance for the Wearable breast pump (model S12A), a Pump, Breast, Powered (Class II — Special Controls, product code HGX), submitted by Shenzhen TPH Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 21, 2025, 160 days after receiving the submission on November 12, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K243508 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 12, 2024 |
| Decision Date | April 21, 2025 |
| Days to Decision | 160 days |
| Submission Type | Abbreviated |
| 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 |