Cleared Traditional

K983776 - EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP

K983776 is an FDA 510(k) clearance for EVENFLO COMFORT CONTROL BREAST PUMP, manufactured by Evenflo Co., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K983776 · Evenflo Co., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
182d
Days
Class 2
Risk

K983776 is an FDA 510(k) clearance for the EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Evenflo Co., Inc. (Washington D.C., US). The FDA issued a Cleared decision on April 26, 1999 after a review of 182 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.

View all Evenflo Co., Inc. devices

FDA 510(k) Submission Details - K983776

510(k) Number K983776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1998
Decision Date April 26, 1999
Days to Decision 182 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
22d slower than avg
Panel avg: 160d · This submission: 182d
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 165
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K983776.
PLAYTEX BREAST PUMP
K022594 · Playtex Products, Inc. · Nov 2002
MEDELA SYMPHONY BREAST PUMP, MODEL 024
K020518 · Medela, Inc. · Mar 2002
LACTATION TECHNIQUES MODEL B
K981549 · Lactation Techniques, Inc. · May 1999
EXPRESSE AND PREMIER POWERED BREAST PUMPS
K973501 · Ameda Medizintechnik AG · Dec 1997
HYDROCHECK MICRO FILTER
K970488 · White River Concepts · Nov 1997
LUXMATIC 12-15 ISC PORTABLE ELECTRIC BREAST PUMP
K971543 · Kaweco GmbH · Sep 1997