Pump In Style® Pro+
FDA 510(k) clearance K253498 · decided 2026-01-22
Clearance details
- K-number
- K253498
- Device name
- Pump In Style® Pro+
- Applicant
- Medela, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-10-29
- Decision date
- 2026-01-22
- Days to decision
- 85 days
- Clearance type
- Special
- Product code
- HGX
- Device class
- 2
- Regulation number
- 884.5160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.