Cleared Traditional

K021739 - LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002

K021739 is an FDA 510(k) clearance for LIMERICK POWERED ELECTRIC BREAST PUMP M..., manufactured by Limerick, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K021739 · Limerick, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
227d
Days
Class 2
Risk

K021739 is an FDA 510(k) clearance for the LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Limerick, Inc. (Burbank, US). The FDA issued a Cleared decision on January 10, 2003 after a review of 227 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K021739

510(k) Number K021739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2002
Decision Date January 10, 2003
Days to Decision 227 days
Submission Type Traditional
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
66d slower than avg
Panel avg: 161d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 235
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K021739.
NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068
K033131 · The First Years, Inc. · Oct 2003
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
EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT
K022933 · Evenflo Company, Inc. · Dec 2002
PLAYTEX BREAST PUMP
K022594 · Playtex Products, Inc. · Nov 2002
WHISPER WEAR BREAST PUMP
K022140 · Whisper Wear · Sep 2002