Cleared Special

K082307 - EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT

K082307 is an FDA 510(k) clearance for EVENFLO COMFORT SELECT PERFORMANCE BREA..., manufactured by Evenflo Company, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Special 510(k) pathway after a 29-day FDA review.

K082307 · Evenflo Company, Inc. · Obstetrics & Gynecology device
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Sep 2008
Decision
29d
Days
Class 2
Risk

K082307 is an FDA 510(k) clearance for the EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Evenflo Company, Inc. (Miamisburg, US). The FDA issued a Cleared decision on September 11, 2008 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K082307

510(k) Number K082307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2008
Decision Date September 11, 2008
Days to Decision 29 days
Submission Type Special
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
132d faster than avg
Panel avg: 161d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K082307.
MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP
K081463 · Medel S.P.A. · Feb 2009
ENDEARE BREAST PUMP
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MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B
K082802 · Learning Curve Brands Inc. the First Years · Oct 2008
DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# 1400
K070435 · Whittlestone, Inc. · Jul 2007
PLAYTEX EMBRACE PETITE BREAST PUMP
K061013 · Playtex Products, Inc. · Aug 2006
MEDELA SWING BREAST PUMP
K053052 · Medela AG · May 2006
K082307 · EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT
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