Cleared Special

K191577 - Willow Wearable Breast Pump 2.0

K191577 is an FDA 510(k) clearance for Willow Wearable Breast Pump 2.0, manufactured by Exploramed Nc7, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Special 510(k) pathway after a 84-day FDA review.

K191577 · Exploramed Nc7, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
84d
Days
Class 2
Risk

K191577 is an FDA 510(k) clearance for the Willow Wearable Breast Pump 2.0. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Exploramed Nc7, Inc. (Mountain View, US). The FDA issued a Cleared decision on September 6, 2019 after a review of 84 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K191577

510(k) Number K191577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2019
Decision Date September 06, 2019
Days to Decision 84 days
Submission Type Special
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
77d faster than avg
Panel avg: 161d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

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 254
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K191577.
Evolve Breast Pump
K190465 · Hygeia II Medical Group, Inc. · Oct 2019
Freestyle Flex
K191653 · Medela AG · Oct 2019
Spectra Cashmere
K191208 · Uzinmedicare Co. · Oct 2019
OPERA, OPERA eco
K190810 · Unimom.Co · Aug 2019
Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump
K182749 · Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd. · Jun 2019
Electric Breast Pump
K182413 · Guangdong Horigen Mother & Baby Products Co., Ltd. · Mar 2019
K191577 · Willow Wearable Breast Pump 2.0
Download PDF FDA Summary Exploramed Nc7, Inc.