Cleared Traditional

K964403 - SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068)

K964403 is an FDA 510(k) clearance for SIMPLICITY TM ELECTRIC/BATTERY BREAST P..., manufactured by The First Years, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K964403 · The First Years, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
70d
Days
Class 2
Risk

K964403 is an FDA 510(k) clearance for the SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068). Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by The First Years, Inc. (Avon, US). The FDA issued a Cleared decision on January 13, 1997 after a review of 70 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.

View all The First Years, Inc. devices

FDA 510(k) Submission Details - K964403

510(k) Number K964403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1996
Decision Date January 13, 1997
Days to Decision 70 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
90d faster than avg
Panel avg: 160d · This submission: 70d
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 162
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K964403.
LUXMATIC 12-15 ISC PORTABLE ELECTRIC BREAST PUMP
K971543 · Kaweco GmbH · Sep 1997
WHITE RIVER AUTOMATIC BREAST PUMP
K964679 · White River Concepts · Jun 1997
DOUBLE UP BREAST PUMP
K964396 · The Natural Choice Co., Inc. · Jun 1997
MEDELAS BREAST PUMP
K950750 · Medela, Inc. · Oct 1995
EGNELL ELITE
K950531 · Hollister, Inc. · Sep 1995
MEDELA BATTERY OPERATED BREAST PUMP
K901344 · Medela, Inc. · Aug 1990