Cleared Traditional

K020375 - THE NURTURE III BREAST PUMP

K020375 is an FDA 510(k) clearance for THE NURTURE III BREAST PUMP, manufactured by Bailey Medical Engineering. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K020375 · Bailey Medical Engineering · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
88d
Days
Class 2
Risk

K020375 is an FDA 510(k) clearance for the THE NURTURE III BREAST PUMP. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Bailey Medical Engineering (Los Osos, US). The FDA issued a Cleared decision on May 3, 2002 after a review of 88 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.

FDA 510(k) Submission Details - K020375

510(k) Number K020375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2002
Decision Date May 03, 2002
Days to Decision 88 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
73d faster than avg
Panel avg: 161d · This submission: 88d
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 254
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K020375.
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
MEDELA SYMPHONY BREAST PUMP, MODEL 024
K020518 · Medela, Inc. · Mar 2002
PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP
K012275 · Limerick, Inc. · Jan 2002
WHITTLESTONE BREASTPUMP
K002696 · Whittlestone, Inc. · Mar 2001
K020375 · THE NURTURE III BREAST PUMP
Download PDF FDA Summary Bailey Medical Engine…