Cleared Traditional

K143498 - LifeGlobal Global HP

K143498 is an FDA 510(k) clearance for LifeGlobal Global HP, manufactured by Life Global Group, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K143498 · Life Global Group, LLC · Obstetrics & Gynecology device
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Jan 2015
Decision
41d
Days
Class 2
Risk

K143498 is an FDA 510(k) clearance for the LifeGlobal Global HP. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Life Global Group, LLC (Gilford, US). The FDA issued a Cleared decision on January 20, 2015 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6180 - 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 - K143498

510(k) Number K143498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2014
Decision Date January 20, 2015
Days to Decision 41 days
Submission Type Traditional
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
120d faster than avg
Panel avg: 161d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQL Device Classification - Class 2, Special Controls

Product Code MQL Media, Reproductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6180
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 - MQL Media, Reproductive

All 259
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K143498.
Sydney IVF PVP
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LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA
K142991 · Life Global Group, LLC · Feb 2015
G-TL
K133568 · Vitrolife, Inc. · Jul 2014
EMBRYOGEN
K140317 · Origio A/S · Jun 2014
ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO
K133912 · Origio A/S · May 2014