| K-number | K253510 |
| Device name | Freestyle Mini Hands-free |
| Applicant | Medela, LLC |
| Product code | HGX |
| Device class | Class II |
| Decision date | Apr 10, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 884.5160 |
The Freestyle™ Mini Hands-free breast pump is an electric breast pump designed for lactating women to express and collect milk from their breasts. It is intended for single-user home use and features two wearable hands-free collection cups connected to a pump unit powered by a rechargeable lithium-ion battery.
The subject device features a microcontroller-based cycling control mechanism, 9 adjustable suction levels in both stimulation and expression phases, stimulation vacuum range of -52 to 161 mmHg, expression vacuum range of -70 to -270 mmHg, and a 4-button user interface with LED display. It differs from the predicate (K241322) primarily in maximum vacuum specification (270 vs. 290 mmHg) and stimulation suction levels (9 vs. 6). Both devices support double pumping and backflow protection.
Testing was conducted per IEC 60601-1 Edition 3.2, IEC 60601-4-2:2024, IEC 62133-2:2017, IEC 60601-1-11 Edition 3.1, IEC 60601-1-2:2014+A1:2020, and ISO 10993-1 for biocompatibility. Software was evaluated at Basic Documentation level per 2023 FDA guidance on device software functions.
The subject and predicate devices share identical indications for use and intended use for breast milk collection. They are similar in technological characteristics, including microcontroller-based control, two-phase pumping, adjustable vacuum levels, 4-button interface, and backflow protection. The differences in vacuum specifications and stimulation levels do not raise different questions of safety and effectiveness, and comprehensive performance testing demonstrates the Freestyle™ Mini is as safe and effective as the predicate device.
View the full FDA submission: accessdata.fda.gov