Cleared Traditional

K093648 - SIMPLISSE ELECTRIC BREASTFEEDING COMPANION

K093648 is an FDA 510(k) clearance for SIMPLISSE ELECTRIC BREASTFEEDING COMPANION, manufactured by Simplisse, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K093648 · Simplisse, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
231d
Days
Class 2
Risk

K093648 is an FDA 510(k) clearance for the SIMPLISSE ELECTRIC BREASTFEEDING COMPANION. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Simplisse, Inc. (San Diego, US). The FDA issued a Cleared decision on July 14, 2010 after a review of 231 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.

FDA 510(k) Submission Details - K093648

510(k) Number K093648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2009
Decision Date July 14, 2010
Days to Decision 231 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
70d slower than avg
Panel avg: 161d · This submission: 231d
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 237
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K093648.
SIMPLYGO BREAST PUMP
K102600 · Evenflo Company, Inc. · Dec 2010
E-BASIC SINGLE BREAST PUMP
K101157 · Mapa GmbH · Sep 2010
SPECTRA SERIES BREAST PUMP
K093145 · Uzinmedicare Co. · Aug 2010
UNIMOM ALLEGRO
K100929 · Blue Egg CO · Jun 2010
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
K093648 · SIMPLISSE ELECTRIC BREASTFEEDING COMPANION
Download PDF FDA Summary Simplisse, Inc.