Medela, LLC · Class II · Cleared Feb 13, 2026
| K-number | K253149 |
| Device name | Motion InBra (YM-8801) wearable breast pump |
| Applicant | Medela, LLC |
| Product code | HGX |
| Device class | Class II |
| Decision date | Feb 13, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 884.5160 |
The Motion InBra (YM-8801) is a wearable powered breast pump intended for lactating women to express and collect milk from their breasts for single-user home use. It operates via a rechargeable lithium-ion battery, features a microcontroller-managed system, and includes a 2-phase expression technology (stimulation and expression modes) with adjustable vacuum levels from 80-280 mmHg and cycling rates from 35-120 cycles per minute depending on mode.
The subject device differs from the predicate Lucy Breast Pump in vacuum level ranges (80-160 mmHg vs 75-280 mmHg in stimulation), cycling rates (100-120 cpm vs 30-100 cpm in stimulation), number of suction levels (9 levels vs 4 for expression and 3 for stimulation), and materials (polypropylene breast shield with silicone inserts and ABS motor housing vs circular polypropylene flange). Both share wearable design, lithium-ion power, microcontroller cycling control, 2-phase expression patterns, backflow protection, and adjustable suction levels.
Biocompatibility testing per ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (sensitization and irritation); electrical safety per ANSI/AAMI ES60601-1:2005/A2:2010, IEC 62133-2:2017, and IEC 60601-1-11:2015; electromagnetic compatibility per IEC 60601-1-2:2014 and FDA EMC guidance (June 2022); software evaluated per 2023 FDA guidance on device software functions.
The subject device has the same indications for use, patient population, regulatory classification, and core technological features (wearable design, 2-phase expression, lithium-ion power, backflow protection) as the predicate Lucy Breast Pump. Although there are differences in vacuum specifications, materials, and suction level increments, the applicant argues these differences do not raise new safety or effectiveness concerns because both devices function identically in intended purpose and all performance testing (vacuum verification, backflow protection, use-life, battery performance, and biocompatibility) demonstrates the subject device is as safe and effective as the predicate.
View the full FDA submission: accessdata.fda.gov