Cleared Traditional

K100929 - UNIMOM ALLEGRO

K100929 is an FDA 510(k) clearance for UNIMOM ALLEGRO, manufactured by Blue Egg CO. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K100929 · Blue Egg CO · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
72d
Days
Class 2
Risk

K100929 is an FDA 510(k) clearance for the UNIMOM ALLEGRO. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Blue Egg CO (Daejon, Korea, KR). The FDA issued a Cleared decision on June 16, 2010 after a review of 72 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. 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.

FDA 510(k) Submission Details - K100929

510(k) Number K100929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2010
Decision Date June 16, 2010
Days to Decision 72 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 161d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 K100929.
E-BASIC SINGLE BREAST PUMP
K101157 · Mapa GmbH · Sep 2010
SPECTRA SERIES BREAST PUMP
K093145 · Uzinmedicare Co. · Aug 2010
SIMPLISSE ELECTRIC BREASTFEEDING COMPANION
K093648 · Simplisse, Inc. · Jul 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
DEBP
K092783 · Enko , Ltd. · Oct 2009
K100929 · UNIMOM ALLEGRO
Download PDF FDA Summary Blue Egg CO