Cleared Special

K033131 - NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068

K033131 is an FDA 510(k) clearance for NATURAL COMFORT DOUBLE ELECTRIC/BATTERY..., 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 30-day FDA review.

K033131 · The First Years, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
30d
Days
Class 2
Risk

K033131 is an FDA 510(k) clearance for the NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068. 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 October 30, 2003 after a review of 30 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 - K033131

510(k) Number K033131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2003
Decision Date October 30, 2003
Days to Decision 30 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
131d faster than avg
Panel avg: 161d · This submission: 30d
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 K033131.
WHITTLESTONE EXPRESSER
K051112 · Whittlestone, Inc. · Sep 2005
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 BATTERY/ELECTRIC BREAST PUMP
K032566 · The First Years, Inc. · Sep 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
K033131 · NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068
Download PDF The First Years, Inc.