Cleared Traditional

K172772 - Freemie Independence, Freemie Liberty

K172772 is an FDA 510(k) clearance for Freemie Independence, manufactured by Dao Health. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K172772 · Dao Health · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
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Oct 2017
Decision
29d
Days
Class 2
Risk

K172772 is an FDA 510(k) clearance for the Freemie Independence, Freemie Liberty. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Dao Health (El Dorado Hills, US). The FDA issued a Cleared decision on October 13, 2017 after a review of 29 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dao Health devices

FDA 510(k) Submission Details - K172772

510(k) Number K172772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2017
Decision Date October 13, 2017
Days to Decision 29 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d faster than avg
Panel avg: 160d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

HGX Device Classification - Class 2, Special Controls

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

Regulatory Technology Services, LLC
MARK JOB

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 204
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K172772.
The Pump by Babyation
K173699 · Babyation, LLC · Apr 2018
Electric Breast Pump
K172989 · Joytech Healthcare Co. , Ltd. · Dec 2017
One Mum Pumpset
K172067 · Ardo Medical AG · Nov 2017
Yooeehouse Breast Pump
K163183 · Nantong Poly Technology Co., Ltd. · Oct 2017
Moxxly Flow Collection System
K170722 · Moxxly, Inc. · Aug 2017
Youha electric breast pump
K163136 · Ningbo Youhe Electrical Appliance Technology Co., Ltd. · Jul 2017

FDA 510(k) Resources - Obstetrics & Gynecology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.