Cleared Special

K092770 - SIMPLYGO HANDS FREE BREAST PUMP

K092770 is an FDA 510(k) clearance for SIMPLYGO HANDS FREE BREAST PUMP, 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 30-day FDA review.

K092770 · Evenflo Company, Inc. · Obstetrics & Gynecology device
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Oct 2009
Decision
30d
Days
Class 2
Risk

K092770 is an FDA 510(k) clearance for the SIMPLYGO HANDS FREE BREAST PUMP. 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 October 9, 2009 after a review of 30 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 - K092770

510(k) Number K092770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2009
Decision Date October 09, 2009
Days to Decision 30 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d faster than avg
Panel avg: 161d · This submission: 30d
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 K092770.
AMEDA PLATINUM BREAST PUMP
K100435 · Evenflo Company, Inc. · May 2010
NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP
K100385 · Luv N' Care, Ltd. · Mar 2010
DEBP
K092783 · Enko , Ltd. · Oct 2009
MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP
K081463 · Medel S.P.A. · Feb 2009
ENDEARE BREAST PUMP
K081932 · Hygeia Medical, Inc. · Jan 2009
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
K092770 · SIMPLYGO HANDS FREE BREAST PUMP
Download PDF Evenflo Company, Inc.