Cleared Traditional

K051926 - LIMERICK PJ'S COMFORT JR PORTABLE ELECT...

K051926 is an FDA 510(k) clearance for LIMERICK PJ'S COMFORT JR PORTABLE ELECT..., 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 147-day FDA review.

K051926 · Limerick, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Dec 2005
Decision
147d
Days
Class 2
Risk

K051926 is an FDA 510(k) clearance for the LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Limerick, Inc. (Kanopolis, US). The FDA issued a Cleared decision on December 12, 2005 after a review of 147 days - within the typical 510(k) review window.

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.

View all Limerick, Inc. devices

FDA 510(k) Submission Details - K051926

510(k) Number K051926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2005
Decision Date December 12, 2005
Days to Decision 147 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 160d · This submission: 147d
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 148
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