Cleared Traditional

K012275 - PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP

K012275 is an FDA 510(k) clearance for PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP, 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 172-day FDA review.

K012275 · Limerick, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
172d
Days
Class 2
Risk

K012275 is an FDA 510(k) clearance for the PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP. 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 7, 2002 after a review of 172 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 - K012275

510(k) Number K012275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2001
Decision Date January 07, 2002
Days to Decision 172 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
11d slower than avg
Panel avg: 161d · This submission: 172d
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 K012275.
WHISPER WEAR BREAST PUMP
K022140 · Whisper Wear · Sep 2002
THE NURTURE III BREAST PUMP
K020375 · Bailey Medical Engineering · May 2002
MEDELA SYMPHONY BREAST PUMP, MODEL 024
K020518 · Medela, Inc. · Mar 2002
WHITTLESTONE BREASTPUMP
K002696 · Whittlestone, Inc. · Mar 2001
LACTATION TECHNIQUES MODEL B
K981549 · Lactation Techniques, Inc. · May 1999
EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP
K983776 · Evenflo Co., Inc. · Apr 1999