Cleared Traditional

K962828 - EVERT-IT

K962828 is an FDA 510(k) clearance for EVERT-IT, manufactured by Genesis Industries, Inc.. The device is a Class 1 Obstetrics & Gynecology device with product code HGY cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K962828 · Genesis Industries, Inc. · Obstetrics & Gynecology device
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Feb 1997
Decision
206d
Days
Class 1
Risk

K962828 is an FDA 510(k) clearance for the EVERT-IT. Classified as Pump, Breast, Non-powered (product code HGY), Class I - General Controls.

Submitted by Genesis Industries, Inc. (Elmwood, US). The FDA issued a Cleared decision on February 10, 1997 after a review of 206 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5150 - 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 Genesis Industries, Inc. devices

FDA 510(k) Submission Details - K962828

510(k) Number K962828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1996
Decision Date February 10, 1997
Days to Decision 206 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 160d · This submission: 206d
Pathway characteristics
Predicate-based equivalence.

HGY Device Classification - Class 1, General Controls

Product Code HGY Pump, Breast, Non-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.5150
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HGY Pump, Breast, Non-powered

All 9
Devices cleared under the same product code (HGY) and FDA review panel - the closest regulatory comparables to K962828.
AMEDA HYGIENIKIT
K011519 · Hollister, Inc. · Aug 2001
WHITE RIVER MINI MANUAL BREAST PUMP
K971231 · White River Concepts · May 1997
MEDELA'S FOOT PUMP
K952034 · Medela, Inc. · Sep 1995
MOTHERS TOUCH ONE HAND BREAST PUMP
K912355 · Hollister, Inc. · Dec 1993
SUPPLEMENTAL FEEDING SYSTEM
K844297 · Medela, Inc. · Feb 1985
NEW MOTHER'S WAY-BREAST PUMP
K834399 · Huntleigh Technology, Inc. · Jan 1984