K211016 is an FDA 510(k) clearance for the Powered Breast Pump (Models 7V and 7X). This device is classified as a Pump, Breast, Powered (Class II - Special Controls, product code HGX).
Submitted by Haenim Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on June 29, 2022, 450 days after receiving the submission on April 5, 2021.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K211016 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2021 |
| Decision Date | June 29, 2022 |
| Days to Decision | 450 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 |