Cleared Traditional

K130349 - FREEMIE BREAST COLLECTION SYSTEM

K130349 is an FDA 510(k) clearance for FREEMIE BREAST COLLECTION SYSTEM, 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 206-day FDA review.

K130349 · Dao Health · Obstetrics & Gynecology device
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Sep 2013
Decision
206d
Days
Class 2
Risk

K130349 is an FDA 510(k) clearance for the FREEMIE BREAST COLLECTION SYSTEM. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Dao Health (California, US). The FDA issued a Cleared decision on September 6, 2013 after a review of 206 days - an extended review 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: 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 Dao Health devices

FDA 510(k) Submission Details - K130349

510(k) Number K130349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2013
Decision Date September 06, 2013
Days to Decision 206 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
46d slower than avg
Panel avg: 160d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - HGX Pump, Breast, Powered

All 204
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K130349.
NATURE'S BOND 600 AND NATURE'S BOND 603
K142168 · Devon Medical Products, Inc. · Dec 2014
ARDO CARUM AND CALYPSO POWERED BREAST PUMPS
K141742 · Ardo Medical AG · Oct 2014
ELECTRIC BREAST PUMP
K132882 · Shantou Xinghe Electrical Apparatuses Co., Ltd. · Apr 2014
EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP
K131153 · Evenflo Feeding Incorporated · Jun 2013
MEMORY PUMP MODEL Y4947
K131027 · Tomy International · May 2013
NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP
K121478 · Mapa GmbH · Apr 2013