Ameda, Inc.

FDA Device Registration & Listing · Austin, TX, US · Registration 3009974348

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009974348
FEI Number
3009974348
Entity Name
Ameda, Inc.
City/State/Country
Austin, TX, US
Establishment Address
8206 Cross Park Dr, Austin, TX 78754, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Ameda, Inc. (Owner Number: 10042362)
Owner / Operator Contact Address
8206 Cross Park Drive, Austin, TX 78754, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K221576
PMA Number
N/A

All Registered Proprietary Names

GLO Wearable Breast Pump Bottle, Hot/Cold Water Manual Breast Pump Manual Breast Pump HygieniKit Milk Collection System Mya Joy Plus Breast Pump Elite Breast Pump Pearl Breast Pump

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2025-04-29
FPF Bottle, Hot/Cold Water General Hospital Class 1 880.6085 2016-12-16
HGY Pump, Breast, Non-Powered Obstetrics/Gynecology Class 1 884.5150 2012-11-19
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2012-11-19
HGY Pump, Breast, Non-Powered Obstetrics/Gynecology Class 1 884.5150 2012-11-19
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2021-04-27
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2012-11-19
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2022-11-15

Official Correspondent

Amy Pieper

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ameda, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K190465 Hygeia II Medical Group, Inc. Evolve Breast Pump 2019-10-18
K021739 Limerick, Inc. LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002 2003-01-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009974348. Last updated year: 2026. Please use registration number 3009974348 when referencing this establishment in official correspondence.
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