Data / Medical devices / United States / Willow Innovations Inc.

Willow Innovations Inc.: FDA-registered device maker in Mountain View, CA, United States, 7 510(k) clearances

Name: Willow Innovations Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Willow Innovations Inc. is registered with the FDA (registration 3012759464) in Mountain View, CA, United States. It lists 7 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 27, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012759464
Address: 1975 W. El Camino Real Suite 101, Mountain View, CA, United States, 94040
Owner or operator: Willow Innovations, Inc (10052700)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: September 15, 2016
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure	PWA	1	Manufacturer, Specification developer	accessdata.fda.gov
Breast Pump Kit	OHH	2	Specification developer	accessdata.fda.gov
Nursing Pad, Hydrogel	NTC	1	Specification developer	accessdata.fda.gov
Pump, Breast, Non-Powered	HGY	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Pump, Breast, Powered	HGX	2	Manufacturer, Specification developer	accessdata.fda.gov
Shield, Nipple	HFS	1	Specification developer	accessdata.fda.gov
Vibrator For Therapeutic Use, Genital	KXQ	2	Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 27, 2024	K242125	Elvie Stride 2	HGX	Substantially Equivalent	Chiaro Technology, Ltd.	accessdata.fda.gov
October 16, 2023	K230570	Willow Generation 3 Breast Pump	HGX	Substantially Equivalent	Willow Innovations, Inc.	accessdata.fda.gov
February 9, 2022	K213311	Lucy Breast Pump	HGX	Substantially Equivalent	Willow Innovations, Inc.	accessdata.fda.gov
August 25, 2021	K210936	Elvie Stride	HGX	Substantially Equivalent	Chiaro Technology Limited	accessdata.fda.gov
September 6, 2019	K191577	Willow Wearable Breast Pump 2.0	HGX	Substantially Equivalent	Exploramed Nc7, Inc.	accessdata.fda.gov
October 10, 2018	K181863	Elvie Pump	HGX	Substantially Equivalent	Chiaro Technology Limited	accessdata.fda.gov
August 11, 2016	K161266	Athena Breast Pump	HGX	Substantially Equivalent	Exploramed Nc7, Inc.	accessdata.fda.gov

Compare with other makers

Updated September 27, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.