Cleared Special

K172067 - One Mum Pumpset

K172067 is an FDA 510(k) clearance for One Mum Pumpset, manufactured by Ardo Medical AG. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Special 510(k) pathway after a 145-day FDA review.

K172067 · Ardo Medical AG · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
145d
Days
Class 2
Risk

K172067 is an FDA 510(k) clearance for the One Mum Pumpset. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Ardo Medical AG (Unteraegeri, CH). The FDA issued a Cleared decision on November 29, 2017 after a review of 145 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ardo Medical AG devices

FDA 510(k) Submission Details - K172067

510(k) Number K172067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2017
Decision Date November 29, 2017
Days to Decision 145 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
16d faster than avg
Panel avg: 161d · This submission: 145d
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 Consultant

Hogan Lovells US LLP
Yarmela Pavlovic

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 228
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K172067.
GCE704 Breast Pump
K172842 · Globalcare · Jun 2018
The Pump by Babyation
K173699 · Babyation, LLC · Apr 2018
Electric Breast Pump
K172989 · Joytech Healthcare Co. , Ltd. · Dec 2017
Freemie Independence, Freemie Liberty
K172772 · Dao Health · Oct 2017
Yooeehouse Breast Pump
K163183 · Nantong Poly Technology Co., Ltd. · Oct 2017
Moxxly Flow Collection System
K170722 · Moxxly, Inc. · Aug 2017