K253510
Substantially EquivalentFreestyle Mini Hands-free
The Freestyle Mini Hands-free is a wearable breast pump — product code HGX covers powered breast pumps. Medela has been the incumbent in this category for decades; the Mini Hands-free targets the wearable/in-bra segment that Willow, Elvie, and others opened up, and where Medela has been catching up.
Obstetrics/Gynecology panel, Traditional 510(k). HGX has seen high filing volume over the last five years as the wearable pump segment exploded — clearances often bundle multiple configurations (as seen in other recent HGX filings from smaller manufacturers).
Medela LLC out of McHenry, IL. Five-month clock, shorter than typical — which may reflect Medela's well-known predicate lineage in this category.
- Applicant
- Medela, LLC
- Product code
- HGX
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse 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.