Data / Medical devices / United States / Ameda, Inc.

Ameda, Inc.: FDA-registered device maker in Austin, TX, United States, 7 510(k) clearances

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

Ameda, Inc. is registered with the FDA (registration 3009974348) in Austin, TX, United States. It lists 4 device types. The FDA files 7 510(k) clearances under its listings, the newest dated March 20, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009974348
Address: 8206 Cross Park Dr, Austin, TX, United States, 78754
Owner or operator: Ameda, Inc. (10042362)
Roles: Complaint file establishment, Specification developer
First device listed: November 19, 2012
Registered through: 2026
Brand names listed: Bottle, Hot/Cold Water, Elite Breast Pump, GLO Wearable Breast Pump, HygieniKit Milk Collection System, Manual Breast Pump, Mya Joy Plus Breast Pump, Nipple Shield, Pearl Breast Pump and more

Devices it lists

Device	Product code	Class	Role	Source
Bottle, Hot/Cold Water	FPF	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Pump, Breast, Non-Powered	HGY	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Pump, Breast, Powered	HGX	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Shield, Nipple	HFS	1	Complaint file establishment, 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
March 20, 2025	K250463	Ameda GLO Wearable Breast Pump (Model W8S)	HGX	Substantially Equivalent	Shenzhen TPH Technology Co., Ltd.	accessdata.fda.gov
October 12, 2022	K221576	Ameda Pearl Electric Breast Pump	HGX	Substantially Equivalent	Ameda, Inc.	accessdata.fda.gov
April 22, 2021	K203570	Mya Joy PLUS Breast Pump	HGX	Substantially Equivalent	Ameda, Inc.	accessdata.fda.gov
May 28, 2010	K100435	AMEDA PLATINUM BREAST PUMP	HGX	Substantially Equivalent	Evenflo Company, Inc.	accessdata.fda.gov
August 15, 2001	K011519	AMEDA HYGIENIKIT	HGY	Substantially Equivalent	Hollister, Inc.	accessdata.fda.gov
September 22, 1995	K950531	EGNELL ELITE	HGX	Substantially Equivalent	Hollister, Inc.	accessdata.fda.gov
December 10, 1993	K912355	MOTHERS TOUCH ONE HAND BREAST PUMP	HGY	Substantially Equivalent	Hollister, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 10, 2017	78237	Class III	Ongoing	Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect the mother s milk from the breasts of a nursing woman for the purpose of feeding the collected milk to a baby.	Two specific lots was incorrectly manufactured containing a UK power adapter.	accessdata.fda.gov
February 12, 2015	70599	Class II	Terminated	Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary corrugated shipper (16 x 11.02 x 5.12" inner dimensions). The device is indicated	Devices were not sterilized	accessdata.fda.gov

Compare with other makers

Updated March 20, 2025. 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.