Cleared Traditional

K022933 - EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT

K022933 is an FDA 510(k) clearance for EVENFLO COMFORT SELECT AUTO-CYCLE BREAS..., manufactured by Evenflo Company, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K022933 · Evenflo Company, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
89d
Days
Class 2
Risk

K022933 is an FDA 510(k) clearance for the EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Evenflo Company, Inc. (Vandalia, US). The FDA issued a Cleared decision on December 2, 2002 after a review of 89 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 - K022933

510(k) Number K022933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2002
Decision Date December 02, 2002
Days to Decision 89 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
72d faster than avg
Panel avg: 161d · This submission: 89d
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 237
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K022933.
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
LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002
K021739 · Limerick, Inc. · Jan 2003
PLAYTEX BREAST PUMP
K022594 · Playtex Products, Inc. · Nov 2002
WHISPER WEAR BREAST PUMP
K022140 · Whisper Wear · Sep 2002
THE NURTURE III BREAST PUMP
K020375 · Bailey Medical Engineering · May 2002
K022933 · EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT
Download PDF FDA Summary Evenflo Company, Inc.