Cleared Traditional

EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT (K013226) - FDA 510(k) Clearance

Class I Obstetrics & Gynecology device.

K013226 · Evenflo Company, Inc. · Obstetrics & Gynecology device
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Dec 2001
Decision
84d
Days
Class 1
Risk

K013226 is an FDA 510(k) clearance for the EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT. Classified as Pump, Breast, Non-powered (product code HGY), Class I - General Controls.

Submitted by Evenflo Company, Inc. (Canton, US). The FDA issued a Cleared decision on December 20, 2001 after a review of 84 days - a notably fast clearance 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: 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 Evenflo Company, Inc. devices

Submission Details

510(k) Number K013226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2001
Decision Date December 20, 2001
Days to Decision 84 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 160d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.