Cleared Traditional

Mya Joy PLUS Breast Pump (K203570) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203570 · Ameda, Inc. · Obstetrics & Gynecology device
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Apr 2021
Decision
136d
Days
Class 2
Risk

K203570 is an FDA 510(k) clearance for the Mya Joy PLUS Breast Pump. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Ameda, Inc. (Buffalo Grove, US). The FDA issued a Cleared decision on April 22, 2021 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5160 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ameda, Inc. devices

Submission Details

510(k) Number K203570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2020
Decision Date April 22, 2021
Days to Decision 136 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 160d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HGX Pump, Breast, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HGX Pump, Breast, Powered

All 127
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K203570.
Solo, Swing Maxi
K210759 · Medela, LLC · Aug 2021
Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030)
K203148 · Ningbo Youhe Electrical Appliance Technology Co., Ltd. · Jul 2021
Electric Breast Pump
K201152 · Guangdong Horigen Mother & Baby Products Co., Ltd. · May 2021
Electric breast pump (Models: RH-228 and RH-338)
K201903 · Cixi Ruihong Electric Appliance Co., Ltd. · Apr 2021
imani i2
K202037 · Imani Co. · Mar 2021
imani i1
K202045 · Imani Co. · Feb 2021