Cleared Traditional

K043098 - GERBER DOUBLE ELECTRIC BREAST PUMP

K043098 is an FDA 510(k) clearance for GERBER DOUBLE ELECTRIC BREAST PUMP, manufactured by Gerber Products Co.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K043098 · Gerber Products Co. · Obstetrics & Gynecology device
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Dec 2004
Decision
36d
Days
Class 2
Risk

K043098 is an FDA 510(k) clearance for the GERBER DOUBLE ELECTRIC BREAST PUMP. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Gerber Products Co. (Fremont, US). The FDA issued a Cleared decision on December 15, 2004 after a review of 36 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gerber Products Co. devices

FDA 510(k) Submission Details - K043098

510(k) Number K043098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2004
Decision Date December 15, 2004
Days to Decision 36 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 161d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Underwriters Laboratories, Inc.
CHANTEL CARSON

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 K043098.
ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101
K052047 · Avent America, Inc. · Sep 2005
WHITTLESTONE EXPRESSER
K051112 · Whittlestone, Inc. · Sep 2005
ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100
K051413 · Avent America, Inc. · Aug 2005
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

FDA 510(k) Resources - Obstetrics & Gynecology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.