K253498 is an FDA 510(k) clearance for the Pump In Style® Pro+. This device is classified as a Pump, Breast, Powered (Class II - Special Controls, product code HGX).
Submitted by Medela, LLC (Mchenry, US). The FDA issued a Cleared decision on January 22, 2026, 85 days after receiving the submission on October 29, 2025.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K253498 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 2025 |
| Decision Date | January 22, 2026 |
| Days to Decision | 85 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 |