Cleared Special

K032566 - NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP

K032566 is an FDA 510(k) clearance for NATURAL COMFORT BATTERY/ELECTRIC BREAST..., manufactured by The First Years, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Special 510(k) pathway after a 25-day FDA review.

K032566 · The First Years, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
25d
Days
Class 2
Risk

K032566 is an FDA 510(k) clearance for the NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by The First Years, Inc. (Avon, US). The FDA issued a Cleared decision on September 15, 2003 after a review of 25 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 - K032566

510(k) Number K032566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2003
Decision Date September 15, 2003
Days to Decision 25 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
136d faster than avg
Panel avg: 161d · This submission: 25d
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 237
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K032566.
ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100
K051413 · Avent America, Inc. · Aug 2005
GERBER DOUBLE ELECTRIC BREAST PUMP
K043098 · Gerber Products Co. · Dec 2004
NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068
K033131 · The First Years, Inc. · Oct 2003
MEDELA PUMP IN STYLE ADVANCED BREAST PUMP
K031614 · Medela, Inc. · Jun 2003
LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002
K021739 · Limerick, Inc. · Jan 2003
EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT
K022933 · Evenflo Company, Inc. · Dec 2002
K032566 · NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP
Download PDF The First Years, Inc.