Cleared Abbreviated

K081463 - MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K081463 · Medel S.P.A. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
259d
Days
Class 2
Risk

K081463 is an FDA 510(k) clearance for the MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Medel S.P.A. (Cary, US). The FDA issued a Cleared decision on February 6, 2009 after a review of 259 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Medel S.P.A. devices

Submission Details

510(k) Number K081463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2008
Decision Date February 06, 2009
Days to Decision 259 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 160d · This submission: 259d
Pathway characteristics
Standards-based clearance path.

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 Peers - HGX Pump, Breast, Powered

All 234
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K081463.
Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)
K253914 · Shenzhen Root Innovation Technology Co., Ltd. · Apr 2026
Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)
K260239 · Jiangxi AOV Maternity & Baby Products Co., Ltd. · Apr 2026
Freestyle Mini Hands-free
K253510 · Medela, LLC · Apr 2026
Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)
K254258 · Shenzhen Root Innovation Technology Co., Ltd. · Apr 2026
Wearable Breast Pump (Model S21A)
K260033 · Shenzhen TPH Technology Co., Ltd. · Apr 2026
Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C)
K253946 · Shenzhen Root Innovation Technology Co., Ltd. · Apr 2026