Freestyle Mini Hands-free— 510(k) K253510
Substantially EquivalentMedela, LLC
FDA 510(k) clearance K253510 for Freestyle Mini Hands-free, Substantially Equivalent on 2026-04-10. Applicant: Medela, LLC. Device class: 2.
Summary
The Freestyle Mini Hands-free is a powered breast pump from Medela, filed under HGX. The record doesn't describe the design beyond the name.
Class II, 21 CFR 884.5160. The Obstetrics and Gynecology panel reviewed it as a Traditional 510(k).
Medela filed from McHenry, Illinois. Review took 156 days (November 5, 2025 to April 10, 2026).
Clearance details
- Applicant
- Medela, LLC
- Product code
- Product code HGX
- Device class
- Class 2
- Regulation
- 21 CFR 884.5160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code HGX
view all- K262125 — Nenesupply Venus Handsfree Breast Pump (NBP001-HF)
- K261782 — MODO DUO Electric Pump (B11621, B11673)
- K254203 — Wearable Breast Pump (Model S36)
- K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62) +1 more
- K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF)
More clearances from Medela, LLC
view allAdverse events under product code HGX
product code HGX- Injury
- 758
- Other
- 2
- Total
- 760
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.