K250463 is an FDA 510(k) clearance for the Ameda GLO Wearable Breast Pump (Model W8S). This device is classified as 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 March 20, 2025, 30 days after receiving the submission on February 18, 2025.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K250463 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2025 |
| Decision Date | March 20, 2025 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |