Motion InBra (YM-8801) wearable breast pump— 510(k) K253149
Substantially EquivalentMedela, LLC
FDA 510(k) clearance K253149 for Motion InBra (YM-8801) wearable breast pump, Substantially Equivalent on 2026-02-13. Applicant: Medela, LLC. Device class: 2.
Summary
Medela's Motion InBra (YM-8801) wearable breast pump is filed under product code HGX, powered breast pump. The record doesn't describe the pump beyond its name and that code name.
Class II, 21 CFR 884.5160. Obstetrics/Gynecology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Medela filed from Mchenry, Illinois. The decision came 141 calendar days after FDA received it (September 25, 2025 to February 13, 2026), and it was substantially equivalent.
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.