Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )— 510(k) K260538
Substantially EquivalentShenzhen Root Innovation Technology Co., Ltd.
FDA 510(k) clearance K260538 for Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ), Substantially Equivalent on 2026-06-17. Applicant: Shenzhen Root Innovation Technology Co., Ltd.. Device class: 2.
Summary
This clearance covers Shenzhen Root Innovation Technology's Momcozy Wearable Breast Pump in five models: BP420, BP420-A, BP420-B, BP420-C, and BP420-D. It's filed under HGX, powered breast pumps, and the record doesn't say how the models differ.
Class II, 21 CFR 884.5160. Obstetrics/Gynecology is both the classification panel and the review panel. It was a Traditional 510(k).
Root Innovation filed from Shenzhen, China. The decision came 120 calendar days after receipt (February 17 to June 17, 2026).
Clearance details
- Applicant
- Shenzhen Root Innovation Technology Co., Ltd.
- 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
- Shenzhen, CN
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 Shenzhen Root Innovation Technology Co., Ltd.
view all- K254254 — Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)
- K253629 — Momcozy Nasal Aspirator (BN007)
- K260134 — Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02 +1 more
- K253914 — Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)
- K254258 — Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)
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.