Axicare Breast Pump Model

FDA 510(k) K811403 · Neonatal Corp.

Substantially Equivalent

510(k) numberK811403

Submission

Device name
Axicare Breast Pump Model
Applicant
Neonatal Corp.
Mchenry, IL, US
Received
May 18, 1981
Decision date
June 12, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HGX – Pump, Breast, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5160
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HGX

510(k)DeviceApplicantDecision
K261622Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52…HGX · Traditional Philips Consumer Lifestyle B.V.09/03/2026SE
K262774Wearable breast pump (Model: XN/MD-2249BS, ZFHF)HGX · Traditional Guangdong Horigen Mother & Baby Products Co., Ltd.09/01/2026SE
K260643Cimilre Dual MaxHGX · Traditional Cimilre Co., Ltd.08/21/2026SE
K261298Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))HGX · Traditional Guangdong Youmeng Electrical Technology Co., Ltd.08/20/2026SE
K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)HGX · Traditional Shenzhen TPH Technology Co., Ltd.07/24/2026SE
K261199Wearable Breast Pump (Model S32A)HGX · Traditional Shenzhen TPH Technology Co., Ltd.07/13/2026SE
K250070Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)HGX · Traditional Shenzhen Changkun Technology Co., Ltd.06/26/2026SE
K261025Wearable breast pump (QY-101, QY-102, QY-108)HGX · Traditional Shenzhen Qinyi Electronic Technology Co., Ltd.06/25/2026SE
K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)HGX · Traditional Shenzhen Root Innovation Technology Co., Ltd.06/18/2026SE
K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )HGX · Traditional Shenzhen Root Innovation Technology Co., Ltd.06/17/2026SE

More from Shenzhen Root Innovation Technology Co., Ltd.

510(k)DeviceDecision
K811364Axicare Breast ShellHFS · Traditional 08/03/1981SE
K811707Axicut Disposable ScalpelGDX · Traditional 07/20/1981SE

Questions and answers

When was Axicare Breast Pump Model cleared by the FDA?

Axicare Breast Pump Model (K811403) received a 510(k) decision of Substantially Equivalent on June 12, 1981, 25 days after the submission was received.

What is the product code of K811403?

The FDA product code is HGX – Pump, Breast, Powered, a Class II (moderate risk) device regulated under 21 CFR 884.5160.