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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Life Global Group, LLC devices

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
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 160d · 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 168
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K143498.
Continuous Single Culture-NX Complete (CSCM-NXC)
K170602 · Irvine Scientific Sales Co., Inc. · Jun 2017
SAGE Vitrification Kit and SAGE Vitrification Warming Kit
K170560 · CooperSurgical, Inc. · Apr 2017
FreezeKit Cleave , ThawKit Cleave
K150950 · Vitrolife Sweden AB · Dec 2015
SPERMFREEZE SOLUTION
K113786 · Vitrolife Sweden AB · Oct 2012
CONTINUOUS SINGLE CULTURE COMPLETE
K121572 · Irvine Scientific Sales Co., Inc. · Jul 2012
MULTIPURPOSE HANDLING MEDIUM
K121128 · Irvine Scientific Sales Co., Inc. · Jun 2012