Cleared Traditional

Solo, Swing Maxi (K210759) - FDA 510(k) Clearance

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

K210759 · Medela, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
149d
Days
Class 2
Risk

K210759 is an FDA 510(k) clearance for the Solo, Swing Maxi. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Medela, LLC (Mchenry, US). The FDA issued a Cleared decision on August 11, 2021 after a review of 149 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 Medela, LLC devices

Submission Details

510(k) Number K210759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2021
Decision Date August 11, 2021
Days to Decision 149 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
11d faster than avg
Panel avg: 160d · This submission: 149d
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 Consultant

Medela AG
Jenni Vescovo

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K210759.
Synergy Gold (SG) Portable (Models MM011450 and MM011460)
K210124 · Uzinmedicare Co. · Oct 2021
TT Electric Breast Pump, TT Double Electric Breast Pump
K202802 · Wuxi Xinzhongrui Baby Supplies Co., Ltd. · Aug 2021
Elvie Stride
K210936 · Chiaro Technology Limited · 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
Mya Joy PLUS Breast Pump
K203570 · Ameda, Inc. · Apr 2021