K212180 is an FDA 510(k) clearance for the Wearable Breast Pump (Model S12), 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 February 11, 2022, 214 days after receiving the submission on July 12, 2021. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K212180 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 12, 2021 |
| Decision Date | February 11, 2022 |
| Days to Decision | 214 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 |